Associate Director, Audit Management - Medical Device (Remote)

Vertex Pharmaceuticals Incorporated; Boston, Auburn (MA, ME); Remote; USD 149,000 - 224,000; Full time

Job summary

An established industry player is seeking an Audit Management Associate Director to lead compliance audits across GMP suppliers. This pivotal role involves ensuring adherence to regulations and quality standards while managing a risk-based audit program. The successful candidate will collaborate with cross-functional teams, oversee audit activities, and drive process improvements. With a focus on medical device and combination product regulations, this role offers a unique opportunity to impact quality assurance in a dynamic environment. Enjoy flexible work arrangements and comprehensive benefits while making a significant contribution to the company's mission.

Benefits

Comprehensive Benefits

Flexible Work Arrangements

Qualifications

• 8+ years of experience in auditing and compliance in the medical device industry.
• Proven ability to manage risk-based audit programs effectively.

Responsibilities

• Lead and manage GMP audit program ensuring compliance with regulations.
• Collaborate with QA and business leaders to align audit activities.
• Conduct audits and support inspection readiness activities.

Skills

Medical Device Regulations

GMP Standards

Quality Systems

Risk Management

Root Cause Analysis

Education

Bachelor's Degree

Job description

Job Description

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.

Key Duties and Responsibilities:

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.

Travel Requirements:

Up to 30% domestic and international travel.

Knowledge and Skills:

• 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.

Education and Experience:

• 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.

Additional Information:

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 [e-mail].