10 Saint Alphonsus Health System jobs in Boise

**JOB DESCRIPTION**
**Job Summary**
Leads and supervises a team supporting non-clinical healthcare services activities for care management, care review, utilization management, transitions of care, behavioral health, long-term services and supports (LTSS), and/or other program specific service support - ensuring members reach desired outcomes through integrated delivery of care across the continuum. Contributes to overarching strategy to provide quality and cost-effective member care.
**Essential Job Duties**
- Supervises healthcare services operations support team members within Molina's clinical/healthcare services function, which may include care review, care management, and/or correspondence processing, etc.
- Researches and analyzes the workflow of the department, and offers suggestions for improvement and/or changes to leadership; assists with the implementation of changes.
- Conducts employee and team productivity/quality assurance checks and documents results for accuracy and time compliance.
- Provides regular verbal and written feedback to staff regarding performance and opportunities for improvement.
- Assists in the development and implementation of internal desktop processes and procedures.
- Establishes and maintains positive and effective work relationships with coworkers, clients, members, providers, and customers.
**Required Qualifications**
- At least 5 years of operations or administrative experience in health care, preferably within a managed care setting, or equivalent combination of relevant education and experience.
- Strong analytic and problem-solving abilities.
- Strong organizational and time-management skills.
- Ability to multi-task and meet project deadlines.
- Attention to detail.
- Ability to build relationships and collaborate cross-functionally.
- Excellent verbal and written communication skills.
- Microsoft Office suite/applicable software program(s) proficiency.
**Preferred Qualifications**
- Supervisory/leadership experience.
To all current Molina employees: If you are interested in applying for this position, please apply through the Internal Job Board.
Molina Healthcare offers a competitive benefits and compensation package. Molina Healthcare is an Equal Opportunity Employer (EOE) M/F/D/V
Pay Range: $77,969 - $106,214 / ANNUAL
*Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.

**JOB DESCRIPTION**
**Job Summary**
Leads and supervises a team supporting non-clinical healthcare services activities for care management, care review, utilization management, transitions of care, behavioral health, long-term services and supports (LTSS), and/or other program specific service support - ensuring members reach desired outcomes through integrated delivery of care across the continuum. Contributes to overarching strategy to provide quality and cost-effective member care.
**Essential Job Duties**
- Supervises healthcare services operations support team members within Molina's clinical/healthcare services function, which may include care review, care management, and/or correspondence processing, etc.
- Researches and analyzes the workflow of the department, and offers suggestions for improvement and/or changes to leadership; assists with the implementation of changes.
- Conducts employee and team productivity/quality assurance checks and documents results for accuracy and time compliance.
- Provides regular verbal and written feedback to staff regarding performance and opportunities for improvement.
- Assists in the development and implementation of internal desktop processes and procedures.
- Establishes and maintains positive and effective work relationships with coworkers, clients, members, providers, and customers.
**Required Qualifications**
- At least 5 years of operations or administrative experience in health care, preferably within a managed care setting, or equivalent combination of relevant education and experience.
- Strong analytic and problem-solving abilities.
- Strong organizational and time-management skills.
- Ability to multi-task and meet project deadlines.
- Attention to detail.
- Ability to build relationships and collaborate cross-functionally.
- Excellent verbal and written communication skills.
- Microsoft Office suite/applicable software program(s) proficiency.
**Preferred Qualifications**
- Supervisory/leadership experience.
To all current Molina employees: If you are interested in applying for this position, please apply through the Internal Job Board.
Molina Healthcare offers a competitive benefits and compensation package. Molina Healthcare is an Equal Opportunity Employer (EOE) M/F/D/V
Pay Range: $77,969 - $106,214 / ANNUAL
*Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.

**JOB DESCRIPTION**
**Job Summary**
Leads and supervises a team supporting non-clinical healthcare services activities for care management, care review, utilization management, transitions of care, behavioral health, long-term services and supports (LTSS), and/or other program specific service support - ensuring members reach desired outcomes through integrated delivery of care across the continuum. Contributes to overarching strategy to provide quality and cost-effective member care.
**Essential Job Duties**
- Supervises healthcare services operations support team members within Molina's clinical/healthcare services function, which may include care review, care management, and/or correspondence processing, etc.
- Researches and analyzes the workflow of the department, and offers suggestions for improvement and/or changes to leadership; assists with the implementation of changes.
- Conducts employee and team productivity/quality assurance checks and documents results for accuracy and time compliance.
- Provides regular verbal and written feedback to staff regarding performance and opportunities for improvement.
- Assists in the development and implementation of internal desktop processes and procedures.
- Establishes and maintains positive and effective work relationships with coworkers, clients, members, providers, and customers.
**Required Qualifications**
- At least 5 years of operations or administrative experience in health care, preferably within a managed care setting, or equivalent combination of relevant education and experience.
- Strong analytic and problem-solving abilities.
- Strong organizational and time-management skills.
- Ability to multi-task and meet project deadlines.
- Attention to detail.
- Ability to build relationships and collaborate cross-functionally.
- Excellent verbal and written communication skills.
- Microsoft Office suite/applicable software program(s) proficiency.
**Preferred Qualifications**
- Supervisory/leadership experience.
To all current Molina employees: If you are interested in applying for this position, please apply through the Internal Job Board.
Molina Healthcare offers a competitive benefits and compensation package. Molina Healthcare is an Equal Opportunity Employer (EOE) M/F/D/V
Pay Range: $77,969 - $106,214 / ANNUAL
*Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.

**JOB DESCRIPTION**
**Job Summary**
Leads and supervises a team supporting non-clinical healthcare services activities for care management, care review, utilization management, transitions of care, behavioral health, long-term services and supports (LTSS), and/or other program specific service support - ensuring members reach desired outcomes through integrated delivery of care across the continuum. Contributes to overarching strategy to provide quality and cost-effective member care.
**Essential Job Duties**
- Supervises healthcare services operations support team members within Molina's clinical/healthcare services function, which may include care review, care management, and/or correspondence processing, etc.
- Researches and analyzes the workflow of the department, and offers suggestions for improvement and/or changes to leadership; assists with the implementation of changes.
- Conducts employee and team productivity/quality assurance checks and documents results for accuracy and time compliance.
- Provides regular verbal and written feedback to staff regarding performance and opportunities for improvement.
- Assists in the development and implementation of internal desktop processes and procedures.
- Establishes and maintains positive and effective work relationships with coworkers, clients, members, providers, and customers.
**Required Qualifications**
- At least 5 years of operations or administrative experience in health care, preferably within a managed care setting, or equivalent combination of relevant education and experience.
- Strong analytic and problem-solving abilities.
- Strong organizational and time-management skills.
- Ability to multi-task and meet project deadlines.
- Attention to detail.
- Ability to build relationships and collaborate cross-functionally.
- Excellent verbal and written communication skills.
- Microsoft Office suite/applicable software program(s) proficiency.
**Preferred Qualifications**
- Supervisory/leadership experience.
To all current Molina employees: If you are interested in applying for this position, please apply through the Internal Job Board.
Molina Healthcare offers a competitive benefits and compensation package. Molina Healthcare is an Equal Opportunity Employer (EOE) M/F/D/V
Pay Range: $77,969 - $106,214 / ANNUAL
*Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.

**JOB DESCRIPTION**
**Job Summary**
Leads and supervises a team supporting non-clinical healthcare services activities for care management, care review, utilization management, transitions of care, behavioral health, long-term services and supports (LTSS), and/or other program specific service support - ensuring members reach desired outcomes through integrated delivery of care across the continuum. Contributes to overarching strategy to provide quality and cost-effective member care.
**Essential Job Duties**
- Supervises healthcare services operations support team members within Molina's clinical/healthcare services function, which may include care review, care management, and/or correspondence processing, etc.
- Researches and analyzes the workflow of the department, and offers suggestions for improvement and/or changes to leadership; assists with the implementation of changes.
- Conducts employee and team productivity/quality assurance checks and documents results for accuracy and time compliance.
- Provides regular verbal and written feedback to staff regarding performance and opportunities for improvement.
- Assists in the development and implementation of internal desktop processes and procedures.
- Establishes and maintains positive and effective work relationships with coworkers, clients, members, providers, and customers.
**Required Qualifications**
- At least 5 years of operations or administrative experience in health care, preferably within a managed care setting, or equivalent combination of relevant education and experience.
- Strong analytic and problem-solving abilities.
- Strong organizational and time-management skills.
- Ability to multi-task and meet project deadlines.
- Attention to detail.
- Ability to build relationships and collaborate cross-functionally.
- Excellent verbal and written communication skills.
- Microsoft Office suite/applicable software program(s) proficiency.
**Preferred Qualifications**
- Supervisory/leadership experience.
To all current Molina employees: If you are interested in applying for this position, please apply through the Internal Job Board.
Molina Healthcare offers a competitive benefits and compensation package. Molina Healthcare is an Equal Opportunity Employer (EOE) M/F/D/V
Pay Range: $77,969 - $106,214 / ANNUAL
*Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.

Our client, a leading non-profit organization dedicated to providing comprehensive support services, is seeking an experienced Clinical Operations Manager to oversee their therapeutic programs in Boise, Idaho, US . This is a hybrid role, blending remote work flexibility with essential in-person responsibilities. You will be responsible for the efficient and effective day-to-day operations of multiple clinical sites, ensuring the delivery of high-quality patient care. This includes managing staff, optimizing workflows, adhering to regulatory compliance, and contributing to program development and strategic planning. The ideal candidate will have a strong background in healthcare administration or clinical management, with a deep understanding of patient care delivery, operational efficiency, and regulatory requirements (e.g., HIPAA, state licensing). You will lead and mentor a team of healthcare professionals, fostering a positive and productive work environment. Responsibilities include budget management, resource allocation, quality improvement initiatives, and ensuring seamless coordination between clinical teams and administrative functions. The ability to develop and implement operational policies and procedures, troubleshoot complex challenges, and champion best practices in patient safety and satisfaction is paramount. This role requires excellent communication, organizational, and interpersonal skills. You will play a crucial role in ensuring that the organization's mission of providing exceptional community and social care services is met through optimized clinical operations.

Responsibilities:

• Manage the daily operations of clinical service delivery across multiple sites.
• Supervise, train, and mentor clinical and administrative staff.
• Develop and implement operational policies, procedures, and workflows.
• Ensure compliance with all relevant healthcare regulations and standards.
• Monitor and manage departmental budgets and resource allocation.
• Oversee quality improvement initiatives and patient satisfaction surveys.
• Facilitate effective communication and collaboration among clinical teams and departments.
• Troubleshoot operational issues and implement timely and effective solutions.
• Contribute to strategic planning and program development.

Qualifications:

• Bachelor's degree in Healthcare Administration, Public Health, Business Administration, or a related field. Master's degree preferred.
• Minimum of 5 years of experience in healthcare management or clinical operations, preferably within community or social care settings.
• Demonstrated knowledge of healthcare regulations, compliance, and best practices.
• Strong leadership, team management, and interpersonal skills.
• Excellent organizational, problem-solving, and decision-making abilities.
• Proficiency in healthcare management software and electronic health records (EHR) systems.
• Budget management and financial oversight experience.
• Commitment to providing high-quality patient care and supporting community well-being.

Join our dedicated team and make a tangible difference in the lives of those we serve through exceptional clinical operations.

Job Location: Boise, Idaho, US

**What Clinical Operations contributes to Cardinal Health**
As a PRN, this individual will work on the assigned practice's PPS Analytics portal inputting specific information into the charts of assigned patients as well as placing patients into correct clinical stages.
**Location / Hours** - Fully remote, this PRN will work on an as-needed basis (per diem / part-time) setting their own weekly hours and schedule.
**_Responsibilities_**
Information that may be asked to be reviewed and updated (in this role) include the following:
+ Primary and Secondary treatments with dates
+ Laboratory levels with dates
+ Gleason scores and clinical T stages with onset dates
+ Imaging tests with dates and impression (positive, negative, inconclusive
+ Staging patients into correct clinical stages within PPS
**Qualifications:**
+ Licensed medical professionals preferred
+ Ability to work in a group (and independently, given the remote aspect of this role)
+ Strong verbal and written communication skills required
+ Strong customer service skills required
+ Detail oriented
+ Ability to manage several tasks at the same time; Ability to focus on tasks; Ability to evaluate operating conditions; Ability to exercise sound judgment
+ Demonstrated ability to use technology such as computers, smart phones and tablets
**What is expected of you and others at this level**
+ Applies acquired job skills and company policies and procedures to complete standard task
+ Works on routine assignments that require basic problem resolution
+ Refers to policies and past practices for guidance
+ Receives general direction on standard work; receives detailed instruction on new assignments
+ Consults with supervisor or senior peers on complex and unusual problems
#LI-LP
#LI-remote
**Anticipated Hourly Range** $18.10 per hour - 21.30 per hour
**Bonus Eligible** - No
**Benefits:** Paid time off in compliance with applicable laws.
**Application window anticipated to close** : 09/15/2025 * if interested in opportunity, please submit application as soon as possible.
The hourly range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._
_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
_To read and review this privacy notice click_ here (

**Who We Are**
At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward - always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities.
**The Role**
Kyndryl Consult is the fastest growing business within the organization and instrumental to the company's strategic growth objectives. You will play a key leadership role across multi-disciplinary teams, guiding them through complex consulting engagements and be responsible for creating and positioning strategic change agendas within Kyndryl's largest accounts across the C-suite, spanning the intersection between complex Business and IT customer solutions, transformations that impact across the entire customer Eco-system.
As a Consult Partner, you will have a pivotal role in driving profitable growth, leveraging our comprehensive capabilities to build strong client relationships, and leading your team to success. This role demands a strong presence, industry expertise, and the ability to cultivate relationships with CXO-level clients. Your leadership will be critical in fostering talent development and innovation within the organization.
This role will also be leading the overall client engagement and delivering high quality client work alongside senior client stakeholders. Working in a transaction environment which may be pre or post deal, planning post deal implementation, and ultimately supporting execution. Partners will be focused on financial impact, utilization and contribution, client impact and leadership.
**Contribute to Profitable Growth:**
+ Drive significant financial outcomes through signings and revenue targets
+ Ensure sustained growth and profitability, managing margin expectations and backlog growth
+ Support the identification, pursuit and conversion of a pipeline of business development opportunities
+ Undertake scoping and fee negotiation on engagements, while enduring profitability and understanding and containing risk
+ Apply consultative judgment to accurately scope work, negotiate fees, and draft Statements of Work (SOWs) that align with client needs and enable rapid delivery.
+ Leverage a proven track record of consulting and selling digital workplace services, managing large client portfolios and driving revenue growth.
**Client Engagement:**
+ Build and maintain deep relationships with client CXOs and be seen as the 'go to' person and a trusted advisor by senior executives
+ Leading C-level client interactions and consulting initiatives, deliverables and outputs of a deal engagement
+ Demonstrate credibility and experience to advise and deliver on complex consulting engagement
+ Demonstrate a deep understanding of discovery, design, and deployment processes to guide clients through digital workplace transformations.
+ Anticipate and articulate future challenges in digital workplace services, including those driven by Copilot, agentic AI, and evolving office models, to position Kyndryl as a strategic partner.
+ Bring consulting experience-preferably in the Healthcare space-to tailor engagements that resonate with industry-specific needs and priorities.
+ Enhance client satisfaction, as measured by Net Promoter Score (NPS) and new relationship development; Secure client references
**Operational Excellence:**
+ Achieve individual and team utilization targets
+ Lead the design of complex engagements and take responsibility for oversight of delivery, ensuring high performance and customer satisfaction Leadership, Management, People
+ Lead by example; Fostering a culture of continuous personal and professional development and challenging our people to be curious and innovative and supportive for each other. At the same time ensuring that all outcomes are commercially focused, value adding and effectively executed
**Strategic Contribution:**
+ Drive Kyndryl's delivery capability with new and existing clients by leading Digital Workplace-focused transformation programs, services and implementations centered on Collaboration, Virtualization, Contact Center, Employee Experience, and related DWS offerings.
+ Utilize industry and technology expertise to shape and drive the company's strategic initiatives.
+ Align with Kyndryl's strategic vision and contribute to its execution.
+ Drive external eminence and innovation, establishing a strong personal and organizational brand in the industry.
+ Proactively develop thought leadership and intellectual capital
Kyndryl currently does not require employees to be fully vaccinated against COVID-19, however, if you are hired to work at a client, customer, or partner location, you may be required to show proof of vaccination to align with their respective COVID-19 vaccination policies. Those who believe they are eligible may apply for a medical or religious accommodation prior to the start of employment.
**Who You Are**
Who You Are
You're good at what you do and possess the required experience to prove it. However, equally as important - you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused - someone who prioritizes customer success in their work. And finally, you're open and borderless - naturally inclusive in how you work with others.
Required Skills and Experience
+ Candidates with consultative expertise to articulate Digital Workplace challenges and advise on strategies addressing trends like Copilot, Agentic AI, and the future of work are strongly encouraged to apply
+ Experience in discovery, design, and deployment of Digital Workplace solutions using technologies including, but not limited to Microsoft M365, Intune, AVD, Copilot, Viva, ServiceNow ITSM, Amazon Connect, and Google Suite strongly preferred.
+ Extensive experience in client engagement and relationship management at the CXO level
+ Demonstrable ability to build and commercialize relationships with senior executives
+ Proven track record of leading and executing complex projects with multi-disciplinary teams in a consulting, corporate or public sector environment
+ Expertise in mergers and acquisitions (M&A) integration within the Digital Workplace context would be a plus
+ Effective financial acumen with experience in driving revenue growth and managing margins
+ Experience of managing or supporting high-value business development activities with senior stakeholders
+ Deep understanding of industry trends and technology
+ Sound personal brand and presence in the Healthcare industry preferred
+ Demonstrated ability to innovate and drive change
**The compensation range for the position in the U.S. is $159,240 to $86,560 based on a full-time schedule. Your actual compensation may vary depending on your geography, job-related skills and experience. For part time roles, the compensation will be adjusted appropriately. The pay or salary range will not be below any applicable state, city or local minimum wage requirement. There is a different applicable compensation range for the following work locations:**
**California: 175,080 to 343,920**
**Colorado: 159,240 to 286,560**
**New York City: 191,040 to 343,920**
**Washington: 175,080 to 315,240**
**Washington DC: 175,080 to 315,240**
**This position will be eligible for Kyndryl's discretionary annual bonus program, based on performance and subject to the terms of Kyndryl's applicable plans. You may also receive a comprehensive benefits package which includes medical and dental coverage, disability, retirement benefits, paid leave, and paid time off. Note: If this is a sales commission eligible role, you will be eligible to participate in a sales commission plan in lieu of the annual discretionary bonus program. Applications will be accepted on a rolling basis.**
**Being You**
Diversity is a whole lot more than what we look like or where we come from, it's how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we're not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you - and everyone next to you - the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That's the Kyndryl Way.
**What You Can Expect**
With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter - wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed.
**Get Referred!**
If you know someone that works at Kyndryl, when asked 'How Did You Hear About Us' during the application process, select 'Employee Referral' and enter your contact's Kyndryl email address.
Kyndryl is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics. Kyndryl is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

**Job Description**
In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities.
The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.
The incumbent will be accountable for the development of quality plans to implement `quality by design`within clinical development programs, using a risk-based approach.
The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.
**Operational Quality Management:**
+ The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of quality by design principles in assigned clinical trials.
+ The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
+ The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.·
+ The CQOM will facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
+ In partnership with the CQOL, the CQOM will develop skillsets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a profound knowledge of Good Clinical Practice with respect to digital data management (i.e. use of novel technology within clinical trials).
+ The CQOM will build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with our research division QA and acting as the link between Clinical Development, study teams, global business functions and regional study management.
+ The CQOM, in partnership with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.
+ The CQOM is accountable for ensuring comprehensive oversight of all activities delegated to third parties.
**This will include, but not be limited to:**
+ Facilitating and monitoring CTT oversight of vendors
+ Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies).
+ Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. NGO, government or academic institutions).
**Inspection Preparation and Management:**
+ The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities. The CQOM is responsible for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide. Under the guidance of the CQO Lead, the CQOM may be assigned as Point of Contact for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.
+ Work with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
+ Develops, updates, and maintains GCP inspection procedures and guidelines within GCTO.
+ Contributes to the development and/ or revision of Company policies, SOPs and training materials.
+ Develops the strategy for management/support for GCP inspections of Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company's dedication to regulatory compliance.
+ Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, PV, GRACS, IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
+ In collaboration with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.
+ Acts as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance.
+ Escalates potentially significant inspection findings/compliance risks/impact to Company Senior Management.
+ Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
**CAPA Management Support:**
+ Ensures that all actions and commitments related to audits and inspections are implemented in a timely manner. Tracks all inspection CAPA and regulatory commitments and checks evidence of completion.
+ Ensures repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
+ Provides guidance and support for CCQMs regarding inspections at a country level sites that require a Company headquarters input.
**Other activities:**
+ Provides input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.
+ Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
+ Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed.
**Education:**
+ B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area. Further formal education in quality management or business management is preferred.
**Prerequisites:**
+ Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.
+ Profound knowledge and comprehension of clinical development programs, clinical trial processes as well as quality management systems and quality control tools.
+ Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
+ Has delivered effective CAPA management solutions.
+ Has worked with risk management tools and processes within the clinical quality framework.
**Skills:**
+ Superior oral and written communication skills in an international environment.
+ Ability to manage and develop others, including formal performance management when necessary.
+ Excellent project management and organizational skills.
+ Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
+ Ability to lead cross-functional teams of business professionals within and outside our Research division
+ Able to act urgently for worldwide health authority inspection matters.
+ Ability to analyze, interpret and solve complex problems.
+ Ability to think strategically and objectively and with creativity and innovation.
+ Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results.
+ Ability to identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.
Current Employees apply HERE ( Contingent Workers apply HERE ( and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here ( if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights ( GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts ( Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The salary range for this role is
$139,600.00 - $219,700.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
No
**Required Skills:**
Adaptability, Clinical Quality Management, Clinical Study Design, Clinical Trial Planning, Clinical Trials Monitoring, Communication, Data Analysis, ICH GCP Guidelines, Management Process, Medical Writing, Process Improvements, Regulatory Compliance, Risk Management, Social Collaboration, Strategic Planning, Strategic Thinking, Team Leadership, Training and Development
**Preferred Skills:**
**Job Posting End Date:**
09/19/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R