Associate Director, GMP Operational Quality (Biologics and Devices)

Vertex Inc.; Boston (MA); Hybrid; USD 95,000 - 142,000; Full time

Job summary

Vertex is seeking an Associate Director, GMP Operational Quality Assurance in Boston to lead day-to-day quality operations across complex programs. This role partners with Product Quality Leads, MSAT, Regulatory Affairs, and external CDMOs to ensure patient safety, product quality, and regulatory compliance.

The role requires extensive experience in cGMP biologics and the ability to mentor teams, analyze quality metrics, and drive CAPA and risk-based decisions.

Qualifications

• Bachelor’s degree in a scientific or allied health field
• Typically requires 8+ years of relevant GMP Quality experience, including leadership of complex quality initiatives and QA oversight of external manufacturing operations

Responsibilities

• Lead cross-functional collaboration with Manufacturing, Quality Control, MSAT and Regulatory Affairs to resolve deviations and ensure compliance.
• Represent Quality on cross-functional teams as a senior technical resource and decision-maker.
• Provide Quality oversight of change controls, investigations, CAPAs, and batch records for external drug substance disposition.
• Review regulatory submissions and support audits to ensure technical accuracy and regulatory alignment.

Skills

Leadership

Quality risk mgmt

Cross-functional collaboration

Decision making

Mentoring

Communication

Independent work

Education

Bachelor's degree in science or allied health

Tools

QDocs

TrackWise

Veeva

Job description

Job Description

General Summary:

The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible for strategic and operational Quality oversight across multiple complex programs. This role leads day-to-day quality operations, supports the execution of new initiatives, and applies sound judgment to resolve complex quality and compliance issues. The role provides Quality oversight for drug substance disposition from development through process performance qualification, ensuring decisions align with patient safety, product quality, regulatory expectations, and business continuity.

This role serves as a visible Quality partner to Product Quality Leads, MSAT, Regulatory Affairs, operational stakeholders, CDMOs, and suppliers. The successful candidate will be a key member of the Vertex Biologics and Devices Quality Team, influencing cross-functional alignment, proactively managing risk, and providing timely quality direction in support of external drug substance manufacturing and disposition.

Key Duties and Responsibilities:

• Lead cross-functional collaboration with Manufacturing, Quality Control, MSAT, Regulatory Affairs, and other Quality functions to resolve complex deviations and align decisions with patient safety, product quality, and regulatory compliance
• Represent Quality on cross-functional teams as a senior technical resource and decision-maker
• Lead drafting, negotiation, and oversight of Quality Agreements with CDMOs, suppliers, and Vertex, as needed
• Provide Quality oversight and direction to Change Control owners to ensure compliance with procedural and regulatory expectations
• Initiate, assess, and approve change controls, as appropriate, using risk-based decision-making
• Provide Quality leadership and technical expertise for deviation investigations, including OOS/OOT events, by ensuring robust root cause analysis and timely, effective CAPA implementation
• Review and approve complex investigations and CAPAs to ensure scientific rigor, compliance, and sustainable corrective actions
• Review and approve master and executed batch records to support external drug substance disposition activities
• Analyze Quality Metrics and performance trends to identify risks, drive continuous improvement, and inform Quality leadership decisions
• Develop and recommend strategies to address compliance gaps and strengthen cross-functional quality systems
• Lead or contribute to operational review and escalation meetings to ensure Quality issues are appropriately prioritized, assessed, escalated, and resolved for external drug substance manufacturing operations
• Drive completion of assigned QLT action items by coordinating stakeholders, clarifying expectations, and ensuring timely follow-through
• Proactively identify, assess, communicate, and mitigate quality and compliance risks across assigned programs and external manufacturing activities
• Provide technical Quality guidance during partner and regulatory agency audits
• Review regulatory submissions, as needed, to ensure technical accuracy, clarity, and alignment with current regulatory expectations
• Drive Quality readiness for major development milestones including IND/IMPD submissions, clinical supply manufacturing, PPQ, and regulatory inspections
• Ensure quality risks are proactively identified and escalated within program governance

Knowledge and Skills:

• In-depth knowledge of cGMP principles and their practical application in a biologics pharmaceutical setting, including global GMP manufacturing requirements
• Demonstrated leadership and influence across matrixed teams, with the ability to set direction, drive accountability, and deliver quality outcomes in a fast-paced environment
• Experience leading complex quality initiatives with contract manufacturing organizations, including cross-functional planning, issue escalation, stakeholder alignment, and continuous improvement
• Advanced experience identifying, assessing, communicating, and mitigating quality and compliance risks using quality risk management principles and sound business judgment
• Ability to mentor and coach less experienced colleagues, build technical capability, and model effective quality decision-making
• Excellent communication and influencing skills, including the ability to translate complex and sensitive quality issues into clear recommendations for cross-functional and external audiences
• Demonstrated ability to operate independently, exercise sound judgment, and provide quality leadership for large, multifaceted projects
• Demonstrated ability to evaluate complex quality matters, make risk-based decisions, synthesize diverse information, and shape practical solutions
• Experience leading complex event investigations, root cause analysis, CAPA strategy, and effectiveness assessments
• Experience with electronic document management systems, such as QDocs, TrackWise, and Veeva

Education and Experience:

• Bachelor’s degree in a scientific or allied health field (or equivalent degree)
• Typically requires 8+ years of relevant GMP Quality experience, including leadership of complex quality initiatives and QA oversight of external manufacturing operations

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$94,600 - $141,800

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:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:

1. Hybrid : work remotely up to two days per week; or select
2. 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.

#LI-Hybrid

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 [e-mail]