570 Audit Management jobs in the United States

We're seeking an experienced audit professional to join our Investment Management audit team as a Director to execute various assurance activities in order to assess risk and formulate a view on the control environment.

The Internal Audit Division (IAD) drives attention and resources to vulnerabilities by providing an independent and well-informed view and impactful messages about the most important risks facing our Firm. This is accomplished by performing a range of assurance activities to independently assess the quality and effectiveness of Morgan Stanley's system of internal control, including risk management and governance systems and processes. IAD serves as an objective and independent function within the Firm's risk management framework to foster continual improvement of risk management processes. This is a Director level position within Business Audit, which is responsible for inspecting controls in front, middle and back offices.

Since 1935, Morgan Stanley is known as a global leader in financial services, always evolving and innovating to better serve our clients and our communities in more than 40 countries around the world.

• Help identify risk and impact to relevant coverage area to prioritize areas of focus
• Execute and lead aspects of assurance activities (e.g., audits, continuous monitoring, closure verification) to assess risk and formulate a view on the control environment
• Facilitate conversations with stakeholders on risks, their impact and how well they are managed in a clear, timely and structured manner
• Assist in managing multiple deliverables in line with team priorities
• Solicit and provide feedback and participate in formal and on-the-job training to further develop self and peers

• Understanding of business line and key regulations relevant to coverage area (asset management experience preferred)
• Strong understanding of audit principles, methodology, tools, and processes (e.g., risk assessments, planning, testing, reporting and continuous monitoring)
• Ability to identify and analyze multiple data sources to inform point of view
• Ability to ask meaningful questions, understand various viewpoints and adapt messaging accordingly
• A commitment to practicing inclusive behaviors
• At least 4 years' relevant experience would generally be expected to find the skills required for this role
• Relevant certifications (i.e., CIA, CPA,CIDA, CAIA, CFA)

WHAT YOU CAN EXPECT FROM MORGAN STANLEY:

We are committed to maintaining the first-class service and high standard of excellence that have defined Morgan Stanley for over 89 years. Our values - putting clients first, doing the right thing, leading with exceptional ideas, committing to diversity and inclusion, and giving back - aren't just beliefs, they guide the decisions we make every day to do what's best for our clients, communities and more than 80,000 employees in 1,200 offices across 42 countries. At Morgan Stanley, you'll find an opportunity to work alongside the best and the brightest, in an environment where you are supported and empowered. Our teams are relentless collaborators and creative thinkers, fueled by their diverse backgrounds and experiences. We are proud to support our employees and their families at every point along their work-life journey, offering some of the most attractive and comprehensive employee benefits and perks in the industry. There's also ample opportunity to move about the business for those who show passion and grit in their work.

Morgan Stanley's goal is to build and maintain a workforce that is diverse in experience and background but uniform in reflecting our standards of integrity and excellence. Consequently, our recruiting efforts reflect our desire to attract and retain the best and brightest from all talent pools. We want to be the first choice for prospective employees.

It is the policy of the Firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, sex stereotype, gender, gender identity or expression, transgender, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy, veteran or military service status, genetic information, or any other characteristic protected by law.

Morgan Stanley is an equal opportunity employer committed to diversifying its workforce (M/F/Disability/Vet).

As a Senior Associate on the Asset Management Audit Team, you will lead all aspects of the audit lifecycle including, planning, fieldwork, reporting, validation and continuous monitoring. The role is highly visible and also offers you exposure to senior executives outside of Internal Audit across the bank.

Job responsibilities

• Plan, execute and document audit activities, including risk assessments, audit planning, audit testing, control evaluation, report drafting and follow-up and verification of issue closure
• Work closely with global Audit colleagues in the early identification of emerging control issues and reporting them timely to Audit management and business stakeholders
• Recognize the confidential nature of Internal Audit communications and access to information; you must be disciplined in protecting the confidentiality and security of information in accordance with firm policy
• Partner with stakeholders, business management, other control groups (i.e. risk management, compliance, fraud prevention), external auditors, and regulators establishing strong working relationships while maintaining independence
• Finalize audit findings and use judgment to provide an overall opinion on the control environment through developing recommendations to strengthen internal controls
• Take ownership of self-development, including stretch assignments, to prepare for greater responsibilities and career growth, and take initiative to seek out opportunity for continued learning
• Stay up to date with industry trends to identify opportunities for game changing innovations or strategic partnerships

• 5+ years of internal or external auditing experience, or relevant Asset Management industry and business experience
• Bachelor's degree (or relevant financial services experience)
• Experience with internal audit methodology and applying concepts in audit delivery and execution
• Solid understanding of internal control concepts, with the ability to evaluate and determine the adequacy of controls by considering business and technology risks in an integrated manner
• Strong interpersonal and influencing skills, with the ability to establish credibility and build strong partnerships with senior business and control partners
• Strong analytical skills particularly in regard to assessing the probability and impact of an internal control weakness
• Flexible to changing business priorities and ability to multitask in a constantly changing environment

• Advanced Degree in relevant discipline
• Prior experience with Big 4 accounting firm and/or internal audit department in financial services industry
• Knowledge of Asset Management products and services, including related fiduciary activities and applicable laws and regulatory requirements

JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.

We offer a competitive total rewards package including base salary determined based on the role, experience, skill set and location. Those in eligible roles may receive commission-based pay and/or discretionary incentive compensation, paid in the form of cash and/or forfeitable equity, awarded in recognition of individual achievements and contributions. We also offer a range of benefits and programs to meet employee needs, based on eligibility. These benefits include comprehensive health care coverage, on-site health and wellness centers, a retirement savings plan, backup childcare, tuition reimbursement, mental health support, financial coaching and more. Additional details about total compensation and benefits will be provided during the hiring process.

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.

JPMorgan Chase & Co. is an Equal Opportunity Employer, including Disability/Veterans

Base Pay/Salary
Jersey City,NJ $99,750.00 - $145,000.00 / year

Associate Director, Audit Management - Medical Device (Remote) Join to apply for the Associate Director, Audit Management - Medical Device (Remote) role at Vertex Pharmaceuticals Associate Director, Audit Management - Medical Device (Remote) Join to apply for the Associate Director, Audit Management - Medical Device (Remote) role at Vertex Pharmaceuticals Job Description The Audit Management Associate Director is responsible for the audit and inspection management for assigned activities, inclusive of internal and external processes. This role has responsibility for design and execution of compliance audits across GMP suppliers through the development of a risk-based audit program designed to support activities across Vertex business functions. This role ensures adherence to applicable regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System. This role may be a generalist but more often specializes in manufacturing, distribution, laboratory, or clinical practices. Regularly applies specialized domain knowledge to assignments and provides technical recommendations to management. Job Description The Audit Management Associate Director is responsible for the audit and inspection management for assigned activities, inclusive of internal and external processes. This role has responsibility for design and execution of compliance audits across GMP suppliers through the development of a risk-based audit program designed to support activities across Vertex business functions. This role ensures adherence to applicable regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System. This role may be a generalist but more often specializes in manufacturing, distribution, laboratory, or clinical practices. Regularly applies specialized domain knowledge to assignments and provides technical recommendations to management. Key Duties And Responsibilities Provides Medical Device/Combination Product Regulation expertise and leadership. Contributes to the overall direction of the GMP audit program, performance, and effectiveness of the audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with regulatory requirements, and guidance, etc. Partners with QA leadership and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations Directs the development and maintenance of the integrated and risk-based GMP Audit Plan and provides leadership in setting the direction to plan development, execution, and adherence Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule Collaborates with other leaders in Global Quality Compliance to provide direction and alignment of risk-based approaches, ensuring that GMP audit strategies and processes are established to: Provide oversight, including budget forecast and tracking, for audits that are outsourced Execute directed or For-Cause audits, as needed Engages in preparation, support and follow-up activities for inspection readiness Supports due-diligence and business development activities, as requested Serve as quality management system representative Participates in collaborative review of impacted SOP/WI Reviews and analyzes key performance Indicator data and trends Analyzes risk and proposes remedial, corrective and /or preventive actions May participate on process improvement initiatives Provides cross-functional support across Vertex Quality Assurance team May manage Audit and Inspection Management Team Members Travel Requirements Up to 30% Domestic / International Travel Knowledge And Skills Advanced/specialized and in-depth knowledge of: Medical Device/Combination Device Regulations and current industry standards GMP audit processes GMP quality systems Regional/international knowledge of GMP regulations CMC documentation Investigation, root cause analysis, and effectiveness check processes, tools, and techniques Change management and risk management principles and process knowledge Education And Experience Bachelor's degree in relevant field is required Typically requires 8 years of experience or the equivalent combination of education and experience Advanced knowledge and experience with Biotherapeutic and Combination Device requirements in applicable specialty areas such as manufacturing, laboratory, or clinical practices Direct industry experience with Medical Device/Combination Products Management and execution of risk-based audit program Health Authority Inspection Programs (Readiness/Preparation/Management) Pay Range $149,300 - $24,000 Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation Remote-Eligible Flex Eligibility Status In this Remote-Eligible role, you can choose to be designated as: Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 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 Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Health Care Provider Referrals increase your chances of interviewing at Vertex Pharmaceuticals by 2x Get notified about new Associate Medical Director jobs in Boston, MA . Regional Medical Associate Director/Director (RMD), Medical Affairs - REMOTE Waltham, MA $194,0 0.00- 213,000.00 1 month ago Associate Medical Director, Drug Safety and Pharmacovigilance (PV) Director, Medical Science Liaison - South, Central, or West Regions Waltham, MA 233,000.00- 246,000.00 1 month ago Medical Research Operations Lead – RWE, Rare Disease Medical Science Liaison - Southeast U.S. Medical Science Liaison (MSL, TED/Graves' Disease)- New England Regional Medical Associate Director/Director (RMD), Scientific Communications - REMOTE We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Who We Are

At OKX, we believe that the future will be reshaped by crypto, and ultimately contribute to every individual's freedom. OKX is a leading crypto exchange, and the developer of OKX Wallet, giving millions access to crypto trading and decentralized crypto applications (dApps). OKX is also a trusted brand by hundreds of large institutions seeking access to crypto markets. We are safe and reliable, backed by our Proof of Reserves. Across our multiple offices globally, we are united by our core principles: We Before Me , Do the Right Thing , and Get Things Done . These shared values drive our culture, shape our processes, and foster a friendly, rewarding, and diverse environment for every OK-er. OKX is part of OKG, a group that brings the value of Blockchain to users around the world, through our leading products OKX, OKX Wallet, OKLink and more.

Role Overview:

The Compliance department at OKX is responsible for the overall compliance culture at the company. We’re a team of risk-minded problem solvers who advise the business on the company’s regulatory obligations and the Compliance risk. We operate a global/local Compliance model, whereby subject matter experts within Central Compliance support local in-country Compliance Officers to ensure their programs are robust, consistent, and meet both local regulatory requirements and internal global standards.

The Senior Manager, Enterprise Exam & Audit Management will own the oversight and tactical execution of internal audits, regulatory exams, and compliance reviews across the organization. Acting as a central liaison between business units, Compliance, Risk, Legal, and external regulators, this leader ensures enterprise-wide preparedness, consistency, and high-quality delivery in all audit and exam activities. The ideal candidate excels in project and stakeholder management, risk-based control design, and working with other compliance stakeholders - driving resolution of compliance gaps.

About the Opportunity:

Centralize and standardize audit/exam processes to improve coordination, consistency, and quality across business lines.

Reduce risk and friction by maintaining a centralized repository of exam artifacts and an efficient audit response process.

Accelerate remediation cycles by implementing robust issue tracking, escalation, and resolution mechanisms.

Enhance regulatory readiness through proactive preparedness exercises, trend analysis, and alignment with regulatory expectations.

Strengthen stakeholder engagement by providing clear status updates, subject matter support, and risk-based recommendations.

What You’ll Be Doing:

Lead the audit/exam lifecycle, including planning, stakeholder engagement, evidence collection, submission, reporting, and closeout.

Build and maintain an Audit/Exam library, serving as a single source of truth for exam history, findings, and artifacts.

Coordinate engagement with regulators, third-party auditors, internal audit teams, and business partners to ensure structured and timely responses.

Support compliance issue resolution, leveraging risk-based methodologies to define actions, timelines, milestones, and closure verification.

Design and enforce SLAs and escalation protocols for audit and exam deliverables, ensuring transparency across the Lines of Defense.

Conduct risk-based reviews and table-top preparedness exercises to identify gaps, test processes, and validate readiness for exams and audits.

Serve as liaison for consent orders and regulatory remediation programs, supporting senior management in execution and monitoring.

Deliver regular reporting to senior leadership and governance bodies, highlighting status, findings, remediation progress, and emerging risks.

Optimize audit/exam processes and tools, recommending improvements to increase scalability, reduce business disruption, and accelerate turnaround.

Mentor and develop team members, fostering strong project management capabilities, regulatory knowledge, and cross-functional collaboration.

What We Look For In You:

6+ years of experience in compliance, risk management, internal audit, or a related governance role within financial services or fintech; with experience managing audits and assisting with regulatory exams.

Proven leadership and project management skills to drive alignment across stakeholder groups to develop and deliver repeatable end-to-end processes and controls.

Have familiarity with AML, money transmission, privacy, and consumer protection regulations, and industry best practices.

Excellent communication and presentation skills and ability to interact and lead discussions comfortably with stakeholders, senior levels of management and regulators.

Ability to establish goals and objectives that support delivery execution for multiple teams.

Proficient analytical and problem-solving skills, with an ability to analyze data, identify trends, and evaluate risk scenarios effectively

Have excellent organizational skills with high attention to detail.

• Undergraduate degree preferred

Nice-to-Have Requirements:

Professional certifications (e.g., CAMS, PMP, CRCM).

Experience in the crypto or digital assets sector, with familiarity around the regulatory landscape for virtual asset service providers (VASPs).

Track record of successfully implementing cross-functional remediation programs, including those involving technology and product-driven solutions.

Perks & Benefits:

Competitive total compensation package

L&D programs and Education subsidy for employees' growth and development

Various team building programs and company events

Wellness and meal allowances

Comprehensive healthcare schemes for employees and dependants

More that we love to tell you along the process!

OKX Statement:

OKX is committed to equal employment opportunities regardless of race, color, genetic information, creed, religion, sex, sexual orientation, gender identity, lawful alien status, national origin, age, marital status, and non-job related physical or mental disability, or protected veteran status. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

The salary range for this position is $143,000 - $257,000

The salary offered depends on a variety of factors, including job-related knowledge, skills, experience, and market location. In addition to the salary, a performance bonus and long-term incentives may be provided as part of the compensation package, as well as a full range of medical, financial, and/or other benefits, dependent on the position offered. Applicants should apply via OKX internal or external careers site.

#LI-JC4 #LI-HYBRID #LI-REMOTE

The Audit Management Associate Director is responsible for managing audit and inspection activities, including internal and external processes. This role involves designing and executing compliance audits across GMP suppliers through a risk-based audit program supporting Vertex's business functions. The role ensures adherence to regulations, industry standards, and Vertex policies, procedures, and quality standards as outlined in the Quality Management System. It may focus on manufacturing, distribution, laboratory, or clinical practices, applying specialized domain knowledge and providing technical recommendations to management.

1. Provide expertise and leadership in Medical Device / Combination Product Regulation.
2. Contribute to the direction, performance, and effectiveness of the GMP audit program, ensuring quality risk management and compliance.
3. Partner with QA leadership and business leaders to coordinate and align audit activities and remediation efforts.
4. Develop and maintain a risk-based GMP Audit Plan, leading its execution and adherence.
5. Engage stakeholders across functions for risk evaluation and audit scheduling.
6. Collaborate with Global Quality Compliance leaders to align risk-based audit strategies.
7. Oversee budget and resources for outsourced audits.
8. Conduct directed or For-Cause audits as needed.
9. Support inspection readiness activities and due diligence processes.
10. Participate in SOP/WI reviews, analyze key performance indicators, and propose corrective actions.
11. Manage process improvements and provide cross-functional support within Vertex Quality Assurance.
12. Manage Audit and Inspection Management Team Members if applicable.

Up to 30% domestic and international travel.

• In-depth knowledge of Medical Device/Combination Product Regulations and GMP standards.
• Experience with GMP audit processes and quality systems.
• Regional/international regulatory knowledge.
• Expertise in CMC documentation, investigation, root cause analysis, and change management.

• Bachelor's degree in a relevant field.
• Typically 8+ years of experience or equivalent combination.
• Experience with biotherapeutic and combination device requirements.
• Industry experience with Medical Devices/Combination Products.
• Proven ability to manage risk-based audit programs and health authority inspections.

Salary range: $149,300 - $224,000. The role is remote-eligible with flexible work arrangements. Vertex offers comprehensive benefits and is committed to equal employment opportunities. For accommodations, contact

Join to apply for the Associate Director, Audit Management - Medical Device (Remote) role at Vertex Pharmaceuticals

Join to apply for the Associate Director, Audit Management - Medical Device (Remote) role at Vertex Pharmaceuticals

Job Description

The Audit Management Associate Director is responsible for the audit and inspection management for assigned activities, inclusive of internal and external processes. This role has responsibility for design and execution of compliance audits across GMP suppliers through the development of a risk-based audit program designed to support activities across Vertex business functions. This role ensures adherence to applicable regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System. This role may be a generalist but more often specializes in manufacturing, distribution, laboratory, or clinical practices. Regularly applies specialized domain knowledge to assignments and provides technical recommendations to management.

Job Description

The Audit Management Associate Director is responsible for the audit and inspection management for assigned activities, inclusive of internal and external processes. This role has responsibility for design and execution of compliance audits across GMP suppliers through the development of a risk-based audit program designed to support activities across Vertex business functions. This role ensures adherence to applicable regulations, industry standards, and to Vertex policies, procedures, and quality standards as set forth in the Quality Management System. This role may be a generalist but more often specializes in manufacturing, distribution, laboratory, or clinical practices. Regularly applies specialized domain knowledge to assignments and provides technical recommendations to management.

Key Duties And Responsibilities

• Provides Medical Device/Combination Product Regulation expertise and leadership.
• Contributes to the overall direction of the GMP audit program, performance, and effectiveness of the audit program in assuring quality risk management/mitigation and the adequacy and adherence to controls for quality and compliance with regulatory requirements, and guidance, etc.
• Partners with QA leadership and business leadership for coordination and alignment in ensuring overall quality of audit and adequacy in remediation/improvement across vendors and internal operations
• Directs the development and maintenance of the integrated and risk-based GMP Audit Plan and provides leadership in setting the direction to plan development, execution, and adherence
• Partners with and engages stakeholders and leadership across functional areas and QA in risk evaluation when determining the internal audit schedule
• Collaborates with other leaders in Global Quality Compliance to provide direction and alignment of risk-based approaches, ensuring that GMP audit strategies and processes are established to:
• Provide oversight, including budget forecast and tracking, for audits that are outsourced
• Execute directed or For-Cause audits, as needed
• Engages in preparation, support and follow-up activities for inspection readiness
• Supports due-diligence and business development activities, as requested
• Serve as quality management system representative
• Participates in collaborative review of impacted SOP/WI
• Reviews and analyzes key performance Indicator data and trends
• Analyzes risk and proposes remedial, corrective and /or preventive actions
• May participate on process improvement initiatives
• Provides cross-functional support across Vertex Quality Assurance team
• May manage Audit and Inspection Management Team Members
  
  

• Up to 30% Domestic / International Travel
  
  

• Medical Device/Combination Device Regulations and current industry standards
• GMP audit processes
• GMP quality systems
• Regional/international knowledge of GMP regulations
• CMC documentation
• Investigation, root cause analysis, and effectiveness check processes, tools, and techniques
• Change management and risk management principles and process knowledge
  
  

• Bachelor's degree in relevant field is required
• Typically requires 8 years of experience or the equivalent combination of education and experience
• Advanced knowledge and experience with Biotherapeutic and Combination Device requirements in applicable specialty areas such as manufacturing, laboratory, or clinical practices
• Direct industry experience with Medical Device/Combination Products
• Management and execution of risk-based audit program
• Health Authority Inspection Programs (Readiness/Preparation/Management)
  
  

• Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
• Hybrid: work remotely up to two days per week; or select
• On-Site: work five days per week on-site with ad hoc flexibility.
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Health Care Provider

Referrals increase your chances of interviewing at Vertex Pharmaceuticals by 2x

Get notified about new Associate Medical Director jobs in Boston, MA .

Waltham, MA $194,0 0.00- 213,000.00 1 month ago

Waltham, MA 233,000.00- 246,000.00 1 month ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

The Audit Management Associate Director is responsible for managing audit and inspection activities, including internal and external processes. This role involves designing and executing compliance audits across GMP suppliers through a risk-based audit program supporting Vertex's business functions. The role ensures adherence to regulations, industry standards, and Vertex policies, procedures, and quality standards as outlined in the Quality Management System. It may focus on manufacturing, distribution, laboratory, or clinical practices, applying specialized domain knowledge and providing technical recommendations to management.

1. Provide expertise and leadership in Medical Device / Combination Product Regulation.
2. Contribute to the direction, performance, and effectiveness of the GMP audit program, ensuring quality risk management and compliance.
3. Partner with QA leadership and business leaders to coordinate and align audit activities and remediation efforts.
4. Develop and maintain a risk-based GMP Audit Plan, leading its execution and adherence.
5. Engage stakeholders across functions for risk evaluation and audit scheduling.
6. Collaborate with Global Quality Compliance leaders to align risk-based audit strategies.
7. Oversee budget and resources for outsourced audits.
8. Conduct directed or For-Cause audits as needed.
9. Support inspection readiness activities and due diligence processes.
10. Participate in SOP/WI reviews, analyze key performance indicators, and propose corrective actions.
11. Manage process improvements and provide cross-functional support within Vertex Quality Assurance.
12. Manage Audit and Inspection Management Team Members if applicable.

Up to 30% domestic and international travel.

• In-depth knowledge of Medical Device/Combination Product Regulations and GMP standards.
• Experience with GMP audit processes and quality systems.
• Regional/international regulatory knowledge.
• Expertise in CMC documentation, investigation, root cause analysis, and change management.

• Bachelor's degree in a relevant field.
• Typically 8+ years of experience or equivalent combination.
• Experience with biotherapeutic and combination device requirements.
• Industry experience with Medical Devices/Combination Products.
• Proven ability to manage risk-based audit programs and health authority inspections.

Salary range: $149,300 - $224,000. The role is remote-eligible with flexible work arrangements. Vertex offers comprehensive benefits and is committed to equal employment opportunities. For accommodations, contact