4,607 Validation Manager jobs in the United States

Job Description

JOB TITLE : Validation Manager

LOCATION : 50 Northern Ave, Boston, MA, 02210

OPENINGS: 1

DUTIES:

• Provides direction and technical leadership to validation contractor(s) to achieve effective and efficient resources utilization.

• Employs a "hands-on approach" to leading the team, managing people, systems and equipment validation activities.

• Ensures that validation work follows all safety standards, conforms to end-user requirements/specifications, cGMP compliance, and that validation activities are tracked and completed within guidelines and schedule.

• Expected to execute tasks and responsibilities with minimal guidance demonstrating outstanding multi-tasking, problem solving and excellent communication skills, in a dynamic and challenging internal manufacturing environment.

• Ensures a robust system is in place for the facility, equipment & laboratory, instruments including utilities, engineering, maintenance, and validation activities.

REQUIREMENTS: Employer will accept a Master's degree in Science or Engineering related field and 3 years of experience in the job offered or in a Validation Manager-related occupation.

Alternatively, employer will accept a Bachelor's degree in Science or Engineering related field and 5 years of experience in the job offered or in a Validation Manager-related occupation.

Position requires demonstrable experience in the following:

Strong knowledge of validation and system implementations in a GMP manufacturing environment.

Able to perform complex assessments for automated processing systems against current industry compliance requirements.

Working knowledge of current CQV methods, including ISPE, ICH, and ASTM E2500 methodology.

Strong understanding of 21 CFR Part 11, USP <1058>, cGMP, and other regulatory guidance for manufacturing equipment, analytical instruments and automated processing systems.

Displays high competence in the utilization of core quality systems such as change control, deviations, investigations, CAPA management and document control.

Rate of Pay: $ - $

CONTACT: Send Resume to Ken Strecker at Reference . EOE.

#LI-DNI

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at

We are seeking a highly skilled and detail-oriented QA Validation Manager to join our team at Medalogix. The ideal candidate will be responsible for overseeing the validation processes for our software products to ensure compliance with regulatory requirements and industry standards.

• Develop and implement validation strategies and protocols for software products
• Lead a team of validation engineers to execute validation activities
• Collaborate with cross-functional teams to ensure validation requirements are met
• Manage the validation process from planning to execution to documentation
• Review and approve validation documentation and reports

• Bachelor's degree in a related field (Computer Science, Engineering, etc.)
• 5+ years of experience in QA validation in the healthcare industry
• Strong knowledge of regulatory requirements (FDA, HIPAA, etc.)
• Experience leading a team of validation engineers
• Excellent communication and interpersonal skills

If you are a proactive and results-driven individual with a passion for quality assurance and validation, we encourage you to apply for the QA Validation Manager position at Medalogix.

We are searching for a detail-oriented, data-driven QA Engineer to join our team. Intellectual curiosity, experience with agile development environments, expert business application testing skills, and experience with automated testing software and processes are critical. If you can break down a process into component parts without losing sight of the big picture, let’s talk!

We believe in establishing long-term relationships with our clients and long-term careers for our employees. We believe that people are the dynamic engines of company growth. Come work hand-in-hand with Microsoft to deliver unrivaled Identity Access Management (IAM) and Human Capital Management (HCM) software and consulting solutions for companies across the globe.

Your profile for success at Elevate HR:
• Technically adept, scrappy, and self-motivated
• Detail-oriented, with strong analytical skills
• Out-of-the-box thinker and leader with a data-informed creative streak
• Flexible, open-minded, and adaptable to project exigencies, changing priorities, and unanticipated product support needs

A few boxes you’ll need to check:
• Undergraduate and/or advanced degree from a top accredited university, with an exceptional academic track record (preference for degrees in Computer Science, Software Engineering, or related field)
• Formal training in Quality Assurance/Testing methodologies, processes, and practices
• Proven ability to execute test plans/cases in accordance with best practices & techniques, gather metrics, record raw data, and prepare test results
• Experience with QA for full-suite HRIS or ERP applications
• Residence in or within easy daily commuting distance from Manhattan, NY
• Authorization to work in the United States now and in the future

A year in the life:
• Adapt and develop QA test methods, protocols, and procedures to ensure that Elevate HR software meets established quality standards for both commercial software products and for software customizations created for customers
• Develop strategy for and maintain QA platforms, environments, and tools for Elevate HR software modules, utilizing both automated and manual test procedures
• Work side-by-side with Elevate HR Software Developers, Architects, and Business Analysts to identify root causes and suggest solutions for application defects
• Create, build, execute and maintain test plans, scripts, and test harnesses
• Prepare complex data sets to test logic, error handling and system workflows
• Support migration to new test automation suite
• Analyze test coverage and results to ensure functionality, proper integration, data integrity, and accuracy
• Execute functional, application, performance, and regression tests

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

Your Role at Baxter
The Design Validation Manager will lead user needs research , user needs capture, and design validation activities for all ITT Infusion system digital applications, Infusion Pumps, Infusion Access Devices, and Infusion Elastomeric Pumps. The role will be based out of our Round Lake, IL location, and relocation assistance may be provided.

What You'll be doing
* Conduct user needs research and collaborate with commercial teams to identify user needs and requirements for the various Infusion products.
* Develop and validate use cases and clinical infusion sequences for Infusion Pumps, Infusion Access Devices, and Infusion Elastomeric Pumps to support user needs.
* Collaborate with design teams to ensure user needs are captured and incorporated into system requirements for all Infusion products.
* Lead design validation activities, including study design, sample size justifications, vendor management, and recruitment of participants for validation and research purposes for all Infusion products.
* Ensure all design validation activities are conducted in accordance with relevant regulations and standards, and industry best practices.
* Collaborate with cross-functional teams to ensure seamless integration of user needs into the overall product development process for all Infusion products.
* Provide expert guidance and support to cross-functional teams as needed to ensure successful execution of design validation activities for all Infusion products.
* Select, develop and retain team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Effectively coach, mentor and motivate others for outstanding performance.

What You'll Bring
* Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
* Minimum of 8 years of experience in design validation, user needs research, and product development. Medical device and infusion system experience preferred.
* Strong understanding of relevant regulations and standards, including FDA and ISO for all Infusion products.
* Excellent analytical, problem-solving, and communication skills.
* Strong collaborative and leadership skills, with the ability to work effectively with cross-functional teams.
* Ability to travel up to 20% of the time as needed.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements.At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a base salary range of $120,000 to $165,000 plus an annual incentive bonus. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

#LI-ASR2

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

The Molecular & Validation Manager is responsible for overseeing the daily operations of the Molecular Department, ensuring high-quality molecular diagnostic testing and regulatory compliance. This role provides leadership in validation studies, quality assurance (QA), and quality control (QC), while optimizing laboratory workflows and personnel management. The Molecular & Validation Manager works closely with senior leadership to drive operational efficiency, maintain regulatory adherence, and promote continuous improvement in molecular diagnostics.

Working Relationships1. Reports To: Vice President of Technical Support2. Directly Supervises: Molecular Laboratory Staff3. Indirectly Supervises: Not Applicable4. Type of Supervision Received: General Direction5. Internal Relationships: Extensive6. External Relationships: Moderate

Essential Duties & Responsibilities

• Oversee daily molecular laboratory operations, including workflow optimization and resource management.
• Ensure timely and accurate molecular diagnostic testing in compliance with CAP, CLIA, and state regulations.
• Develop and implement operational strategies to improve efficiency and reduce turnaround time.
• Supervise and support laboratory staff, fostering a collaborative and high-performance work environment.
• Manage inventory, supplies, and vendor relationships to ensure uninterrupted laboratory function.
• Performs tasks of Molecular Technologist in his/her absence.
• Lead validation studies for new molecular assays, instruments, and workflows.
• Prepare and submit comprehensive validation reports for regulatory review and approval.
• Ensure adherence to CAP, CLIA, and state regulatory requirements for all molecular testing procedures.
• Maintain thorough validation documentation and update standard operating procedures (SOPs) as required.
• Participate in regulatory inspections and audits, ensuring laboratory readiness and compliance.

• Oversee QA/QC programs, including proficiency testing, internal audits, and compliance monitoring.
• Implement and maintain robust quality control measures to ensure result accuracy and reliability.
• Identify and resolve non-conformances, deviations, and compliance risks.
• Regularly review and revise SOPs to align with best practices and evolving regulatory standards.

• Train and mentor laboratory personnel on validation procedures, QA/QC protocols, and regulatory requirements.
• Conduct competency assessments and develop training materials to ensure staff proficiency.
• Foster a culture of continuous learning, professional development, and teamwork within the department.
• Provide performance feedback and participate in personnel evaluations.

• Adheres to dress code, maintaining a neat and professional appearance.
• Completes annual educational and continuing education requirements.
• Ensures patient confidentiality at all times.
• Maintains current knowledge of laboratory policies and regulatory requirements.
• Reports on time and completes tasks within designated deadlines.
• Represents the organization in a positive and professional manner.
• Actively participates in departmental meetings and performance improvement initiatives.
• Complies with all organizational policies and ethical business practices.

• Bachelor's degree in Molecular Biology, Clinical Laboratory Science, or a related field (Master's preferred).
• Minimum of 10+ years of experience in molecular diagnostics, including laboratory management and validation.
• Strong knowledge of CAP, CLIA, and state regulatory requirements.
• Proven experience in validation studies, data analysis, and regulatory reporting.
• Excellent problem-solving, organizational, and leadership skills.
• Strong technical writing skills for preparing validation and regulatory reports.
• Ability to work in a high-complexity laboratory environment with a focus on continuous improvement.
• ASCP certified Technologist in Molecular Biology
• Strong background in Cancer Genomics

Who We Are

Machinify is a leading healthcare intelligence company with expertise across the payment continuum, delivering unmatched value, transparency, and efficiency to health plan clients across the country. Deployed by over 60 health plans, including many of the top 20, and representing more than 160 million lives, Machinify brings together a fully configurable and content-rich, AI-powered platform along with best-in-class expertise. We're constantly reimagining what's possible in our industry, creating disruptively simple, powerfully clear ways to maximize financial outcomes and drive down healthcare costs.

Location: This role is full remote.

The DRG Clinical Validation Manager is responsible for the development and management of our DRG clinical validation solutions, including MS and APR-DRG validation. This role requires expertise in healthcare payment methodologies and audit and review criteria to target key clinical claims for review and recovery. Key responsibilities include production and team management, implementation/ integration support, KPI oversight, and providing assistance to various teams within the organization related to clinical validation. This position also supports the leadership, operations, selection, and content development teams. This role requires a proactive and strategic thinker with strong leadership and analytical skills to drive the success of our clinical solutions and ensure optimal team performance.

• Collaborative Development: Collaborate with a multi-disciplinary team of programmers, operations staff, product leaders, and auditors to bring DRG CV process ideas from creation to implementation.

• Team Leadership: Lead the DRG Clinical Validation team by providing guidance, counsel, and development plans to ensure long-term retention and professional growth while fostering a culture of accountability, innovation and clinical excellence
• Internal and External Claim Support: Support internal team members by coaching, mentoring, and providing performance feedback

• Claims Review Management: Oversee the entire process of clinical claims review, understanding various client configurations and workflows.

• Operational Oversight : Manage scheduling, reporting to management, issue resolution, and execution of plans. Capacity planning to ensure all SLAs are met regularly.
• Clinical Guidance : Work with other clinicians and MDs to provide guidance and feedback on clinical policies, rationales, and references. Help provide feedback on clinical policy performance and suggest adjustments as necessary.

• Work Coordination: Overall management of daily queue inventory. Assign and prioritize work, set goals, and coordinate daily activities of the team. Provide regular updates and communication through one-on-one and team meetings.
• Performance Monitoring: Monitor individual and team results to ensure timely completion of work in accordance with department standards and medical policy guidelines.
• Quality Assurance/Improvement Oversight: Establish and maintain quality assurance standards and continuous improvement processes to ensure clinical validation accuracy and consistency.
• Analytical Problem-Solving: Demonstrate analytical skills to identify problems and trends, develop solutions, and implement action plans.
• Policy and Process Development: Develop departmental policies, processes, and training standards.
• Support and Evidence: Provide internal and external partners with evidence and references supporting industry standards, auditing guidelines, and review stances.

• Performance Reporting: Manage and track data on key performance indicators, including quality scores, workflows, savings, revenue projections, and inventory.
• Solution Development: Collaborate with a multi-disciplinary team to suggestsolution development, including operations, product, data analytics, and technology. Work with testing team to communicate and train the DRG CV team on changes rolled out in software releases.
• Timeline Management: Set timelines and ensure communication on progress, tracking delivery, and escalating roadblocks or dependencies.
• Research and Special Projects: Assist with research, special projects, and ad hoc claim reviews as needed.
• Other Duties: Perform other duties as assigned.

• Bachelor's degree (health administration, business, nursing)
• Equivalent experience of 5+ years in healthcare billing and coding
• Equivalent experience of 3+ years in claims auditing and recovery auditing
• Nursing or MD/DO license required
• Required certifications of CCS, CCDS or CDIP
• Previous 3+ years supervisory experience required

Experience

• Proven experience working within a team, sharing DRG clinical validation audit process knowledge
• Experience with training or education preferred
• Proven experience with Clinical Validation
• Proven knowledge of classification systems, including MS-DRG, APR-DRG, AP-DRG
• Demonstrated curiosity and mastery in understanding the root cause of events and behaviors
• Experience with recovery auditing preferred
• Strong experience in data utilization and insights
• Experience independently structuring and executing complex analyses
• Experience in production and team management
• Experience with Readmission and Short Stay reviews
• Ability to work efficiently and effectively with minimal supervision
• High standards of quality and attention to detail
• Deep understanding of Medicare and Commercial coding rules, regulations, and prospective payment systems
• Superior knowledge of healthcare coding, billing, and reimbursement
• Expert knowledge of clinical criteria documentation requirements
• Subject matter expertise in DRG clinical validation

Computer Equipment and Software

• Experience working with multiple monitors
• Proven success in a remote working environment
• Proficiency in Windows office systems, including the full Microsoft Suite and Teams
• Advanced skills in Microsoft Office (Excel, PowerPoint, Word)
• Experience with various software applications and collaboration with development teams
• Familiarity with multiple encoder/grouper applications

Physical Demands

• Ability to sit or stand for long periods, with occasional stooping and reaching
• May require lifting up to 25 pounds
• Requires a normal range of vision and hearing, with or without accommodation
• Position is not substantially exposed to adverse environmental conditions

This is an exempt position. The salary range is between 125,000 and 140,000 USD

For Salary position only: The salary range is for Base Salary.Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.

What's in it for you

• PTO, Paid Holidays, and Volunteer Days
• Eligibility for health, vision and dental coverage, 401(k) plan participation with company match, and flexible spending accounts
• Tuition Reimbursement
• Eligibility for company-paid benefits including life insurance, short-term disability, and parental leave.
• Remote and hybrid work options

What values we'll share with you

• Ask why
• Think big
• Be humble
• Optimize for customer impact
• Deliver results
  
  

At Machinify, we're reimagining a simpler way forward. This begins with our employees. We are innovators who value integrity, teamwork, accuracy, and flexibility. We do the right thing, and we listen to the needs of our clients and their members. As tenured experts with unmatched experience, we champion diverse perspectives that help us to better understand and serve our clients.

Our values come to life through our culture. We embrace flexible working arrangements that allow our employees to bring innovation to life in the way that best suits their productivity. We work cross-functionally, abandoning silos, to bring innovative and accurate solutions to market. We invest in each other through ongoing education and team celebrations, and we give back to our communities through dedicating days for volunteering. Together, Machinify is making healthcare work better for everyone, and we're passionate about a future with better outcomes for all.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. Machinify is an employment at will employer. We participate in E-Verify as required by applicable law. In accordance with applicable state laws, we do not inquire about salary history during the recruitment process. If you require a reasonable accommodation to complete any part of the application or recruitment process, please contact our People Operations team See our Candidate Privacy Notice at:

• Collaborative Development: Collaborate with a multi-disciplinary team of programmers, operations staff, product leaders, and auditors to bring DRG CV process ideas from creation to implementation.

• Team Leadership: Lead the DRG Clinical Validation team by providing guidance, counsel, and development plans to ensure long-term retention and professional growth while fostering a culture of accountability, innovation and clinical excellence
• Internal and External Claim Support: Support internal team members by coaching, mentoring, and providing performance feedback

• Claims Review Management: Oversee the entire process of clinical claims review, understanding various client configurations and workflows.

• Operational Oversight : Manage scheduling, reporting to management, issue resolution, and execution of plans. Capacity planning to ensure all SLAs are met regularly.
• Clinical Guidance : Work with other clinicians and MDs to provide guidance and feedback on clinical policies, rationales, and references. Help provide feedback on clinical policy performance and suggest adjustments as necessary.

• Work Coordination: Overall management of daily queue inventory. Assign and prioritize work, set goals, and coordinate daily activities of the team. Provide regular updates and communication through one-on-one and team meetings.
• Performance Monitoring: Monitor individual and team results to ensure timely completion of work in accordance with department standards and medical policy guidelines.
• Quality Assurance/Improvement Oversight: Establish and maintain quality assurance standards and continuous improvement processes to ensure clinical validation accuracy and consistency.
• Analytical Problem-Solving: Demonstrate analytical skills to identify problems and trends, develop solutions, and implement action plans.
• Policy and Process Development: Develop departmental policies, processes, and training standards.
• Support and Evidence: Provide internal and external partners with evidence and references supporting industry standards, auditing guidelines, and review stances.

• Performance Reporting: Manage and track data on key performance indicators, including quality scores, workflows, savings, revenue projections, and inventory.
• Solution Development: Collaborate with a multi-disciplinary team to suggestsolution development, including operations, product, data analytics, and technology. Work with testing team to communicate and train the DRG CV team on changes rolled out in software releases.
• Timeline Management: Set timelines and ensure communication on progress, tracking delivery, and escalating roadblocks or dependencies.
• Research and Special Projects: Assist with research, special projects, and ad hoc claim reviews as needed.
• Other Duties: Perform other duties as assigned.

• Bachelor's degree (health administration, business, nursing)
• Equivalent experience of 5+ years in healthcare billing and coding
• Equivalent experience of 3+ years in claims auditing and recovery auditing
• Nursing or MD/DO license required
• Required certifications of CCS, CCDS or CDIP
• Previous 3+ years supervisory experience required

• Proven experience working within a team, sharing DRG clinical validation audit process knowledge
• Experience with training or education preferred
• Proven experience with Clinical Validation
• Proven knowledge of classification systems, including MS-DRG, APR-DRG, AP-DRG
• Demonstrated curiosity and mastery in understanding the root cause of events and behaviors
• Experience with recovery auditing preferred
• Strong experience in data utilization and insights
• Experience independently structuring and executing complex analyses
• Experience in production and team management
• Experience with Readmission and Short Stay reviews
• Ability to work efficiently and effectively with minimal supervision
• High standards of quality and attention to detail
• Deep understanding of Medicare and Commercial coding rules, regulations, and prospective payment systems
• Superior knowledge of healthcare coding, billing, and reimbursement
• Expert knowledge of clinical criteria documentation requirements
• Subject matter expertise in DRG clinical validation

• Experience working with multiple monitors
• Proven success in a remote working environment
• Proficiency in Windows office systems, including the full Microsoft Suite and Teams
• Advanced skills in Microsoft Office (Excel, PowerPoint, Word)
• Experience with various software applications and collaboration with development teams
• Familiarity with multiple encoder/grouper applications

• Ability to sit or stand for long periods, with occasional stooping and reaching
• May require lifting up to 25 pounds
• Requires a normal range of vision and hearing, with or without accommodation
• Position is not substantially exposed to adverse environmental conditions

• PTO, Paid Holidays, and Volunteer Days
• Eligibility for health, vision and dental coverage, 401(k) plan participation with company match, and flexible spending accounts
• Tuition Reimbursement
• Eligibility for company-paid benefits including life insurance, short-term disability, and parental leave.
• Remote and hybrid work options

• Ask why
• Think big
• Be humble
• Optimize for customer impact
• Deliver results