GMP QA Associate Director - Analytical Biologics (Onsite)

Vertex Pharmaceuticals LLC; Boston (MA); Híbrido; USD 154.000 - 231.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work eligibility

On-site work option

Annual bonus

Equity awards

Flexibility in schedule

Descripción de la vacante

Vertex Pharmaceuticals in Boston seeks an expert in quality and regulatory compliance to manage compliance data review for biologics development programs. The role coordinates with Quality Disposition for product release testing and Certificate of Analysis approvals, and leads a team to execute responsibilities.

Reporting to the Director, GMP Operations Quality, this role requires at least 3 days onsite per week in Boston, with strong leadership, data review, and knowledge of GMP/GxP

Formación

• Minimum qualifications as stated: master’s with 5-8 years or bachelor’s with 10+ years.
• Successful people management experience.
• Experience with product stability programs.
• Strong GMP regulatory knowledge and data integrity practices.

Responsabilidades

• Lead QA staff and collaborate with cross functional groups on stability programs.
• QA review of analytical data for Clinical development programs.
• Oversee deviations and investigations (OOS/OOT) and MRB discussions.
• Review and approve method validation and transfer data.
• Coordinate with Quality Disposition for product release data review.
• Provide onsite support for critical batches and COA approvals.
• Perform performance management and development of staff.

Conocimientos

Quality systems

GMP knowledge

Data review

Change controls

Cross-functional collab

Regulatory submission support

Educación

Master’s degree with relevant experience

Bachelor’s degree in scientific/allied health field

Descripción del empleo

Vertex Pharmaceuticals in Boston seeks an expert in quality and regulatory compliance to manage compliance data review for biologics development programs. The role coordinates with Quality Disposition for product release testing and Certificate of Analysis approvals, and leads a team to execute responsibilities.

Reporting to the Director, GMP Operations Quality, this role requires at least 3 days onsite per week in Boston, with strong leadership, data review, and knowledge of GMP/GxP