Associate Director, GMP QA - Analytical Biologics

Vertex Inc. • Boston, MA

1d • $153,900 - $230,900 • Hybrid

About The Position

The Associate Director, GMP QA is recognized as an internal expert in quality and regulatory compliance principles and their application. The role adapts across multiple projects to support corporate goals and regulatory compliance, manages compliance data review for biologics development programs, and coordinates with Quality Disposition teams on development product release testing and Certificate of Analysis approval. The position manages direct reports responsible for executing the team’s work and reports to the Director, GMP Operations Quality.

The role requires at least three onsite days per week at Vertex’s Boston, Massachusetts office. It may be designated hybrid, with remote work up to two days per week, or onsite five days per week, subject to Vertex’s Flex @ Vertex Program policy.

The position oversees analytical quality activities for clinical development and product lifecycle transitions. Responsibilities include stability and analytical data review, deviations and investigations, method validation and transfer oversight, product disposition and release documentation, CMO quality oversight, test article review, change controls, QMS support, compliance risk communication, and staff performance and development. The role also contributes to process improvement and presents performance updates to management and other cross-functional leadership groups.

Requirements

• Master’s degree and 5–8 years of relevant work experience; or a bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10 or more years of relevant work experience; or a relevant comparable background.
• Successful people management experience.
• Previous experience with product stability programs.

Nice To Haves

• Analytical experience, including data review, deviation review, change control, and Quality Systems.
• Adaptability, analytical thinking, data analysis, and attention to detail.
• Broad GxP knowledge and the ability to communicate, collaborate, think critically, and support impact assessments.
• Understanding of technical processes and ability to apply risk-management principles and evaluate risk impact.
• Facilitation, problem-solving, organization, planning, root-cause analysis tools and methodologies, and technical writing skills.
• Working knowledge of GMP regulations and their application; operational QA experience in analytical or manufacturing settings; and experience interpreting GMPs and applicable ICH, USP, ISPE, WHO, or other industry guidance and practices.
• A track record of influencing cross-functional teams; communication, influencing, relationship-management, and conflict-management skills.
• Ability to understand and translate customer needs.
• In-depth knowledge of GMP/GDP regulations and their application.
• Strong Quality Systems background; experience presenting to cross-functional audiences; and coordination and planning experience.
• Critical, analytical, and strategic thinking, including the ability to assess impacts across procedures and systems.
• Cross-functional collaboration and experience with presentation, facilitation, and risk management.
• GMP experience involving ICH expectations for stability.
• Knowledge of analytical techniques and data review.
• Attention to detail, sense of urgency, ability to act quickly, and understanding of escalation processes.
• Previous experience overseeing method validation and transfer.
• Previous CMO oversight experience and broad GMP knowledge across the product lifecycle.
• Ability to negotiate and collaborate with team members to achieve results.
• Preferred experience conducting, hosting, or participating in regulatory, vendor, or internal audits; inspection support; audit processes; and project management.
• Strategic thinking, understanding of agency expectations, and broad GxP understanding.
• Good understanding of GLP standards and experience navigating gray areas.
• Experience supporting review of test article characterization data.
• Previous experience with biomarker testing oversight is helpful.
• Previous regulatory submission review experience and knowledge of regulatory agency requirements.
• Ability to collaborate cross-functionally in a team setting and think strategically with clear goals in mind.

Responsibilities

• Manage Quality staff collaborating with cross-functional technical groups on product stability programs.
• Review analytical data supporting clinical development programs.
• Support analytical deviations and investigations, including out-of-specification (OOS) and out-of-trend (OOT) events; lead Material Review Board discussions as needed.
• Issue stability reports upon request.
• Review RSS and Shipping Excursion Study reports.
• Oversee and conduct method validation and transfer data review for clinical reference standard programs.
• Review and approve internally and externally generated method validation and transfer protocols and reports.
• Support investigations and provide QA guidance for complex investigations.
• Communicate known risks and gaps to management.
• Coordinate with Quality Disposition teams to ensure review and reporting of product release data.
• Perform compliance review of data supporting clinical product disposition.
• Resolve issues with CMOs or internal technical teams.
• Approve Certificates of Analysis and review and approve stability trend reports in a timely manner.
• Identify and discuss stability trends with management.
• Support product transition to commercial, registration-to-validation activities, and PAI readiness.
• Evaluate CMO Quality Systems for compliance with commercial expectations and provide onsite support for critical batches.
• Oversee test articles, including review of production records and data and approval of test article Certificates of Analysis.
• Execute change controls; serve as an owner or assessor, and work with technical teams to resolve gaps and approve change plans and classifications.
• Support QMS deployment as a GMP representative.
• Generate performance updates for presentation to QMT, QLT, and EQLT as needed.
• Communicate gaps and risks, analyze metrics, and participate in process improvement initiatives.
• Manage performance and individual development, including developing goals, conducting performance reviews, and creating Individual Development Plans with employees.
• Ensure timely completion of training requirements before work execution.

Benefits

• Annual bonus and annual equity awards; some roles may also be eligible for overtime pay.
• Medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy.
• Matching charitable donations.
• 401(k).
• Inclusive benefits and resources supporting employees’ career, financial, family, and wellbeing needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Director