Senior Manager

Description:

Vertex Pharmaceuticals is seeking a Senior Manager, GMP Operational Quality for its Boston-based operations. This full-time hybrid position requires a seasoned Quality Assurance professional to lead complex GMP compliance initiatives, collaborate with cross-functional teams, and ensure the highest standards of quality in manufacturing and operational practices. The candidate may choose between working on-site five days a week or a hybrid model with up to two remote workdays per week.

The role involves deep collaboration with internal stakeholders and external partners to resolve sophisticated quality issues, lead change control processes, review batch records, perform quality investigations, and manage CAPA implementation. The Senior Manager will act as a technical expert for audits, regulatory inspections, and quality agreements.

Key Responsibilities:

• Lead resolution of complex quality issues through internal and external collaboration

• Review and enforce Quality Agreements with Contract Manufacturing Organizations (CMOs) and suppliers

• Assess and initiate change controls, ensuring compliance to change procedures

• Oversee root cause analyses, product impact assessments, and corrective action plans

• Review and approve master/executed batch records related to DS, DP, devices, and FG

• Evaluate and enhance cross-functional quality systems and metrics

• Conduct document reviews for GMP-related procedures and protocols

• Coordinate Quality Leadership Team (QLT) activities and follow-ups

• Support internal/external audit processes and regulatory compliance efforts

Required Skills & Knowledge:

• Advanced knowledge of cGMPs in biologics and device manufacturing

• Strong experience in project management, event investigation, and quality system improvements

• Proficiency in risk assessment and mitigation techniques

• Excellent communication and influencing skills across cross-functional teams

• Experience with document management tools such as QDocs, Trackwise, or Veeva

Preferred Qualifications:

• Fluency in quality systems and regulatory requirements in global GMP environments

• Demonstrated leadership in mentoring junior QA staff and driving compliance strategies

Benefits Offered:

• Competitive salary with annual bonus and equity awards

• Medical, dental, and vision benefits

• Student loan repayment assistance

• Generous paid time off, including summer and winter company shutdowns

• 401(k) plan with matching contributions

• Educational assistance and commuting subsidies

• Matching charitable donations

• Comprehensive wellbeing programs