Job Description
The role is recognized as an expert internally in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This role is responsible for managing compliance data review in support of biologics development programs at Vertex. The role is also responsible for coordinating with Quality Disposition teams for review of development program product release testing and Certificate of Analysis approval. This role will manage direct reports to execute the team’s responsibilities.
This position reports to Director, GMP Operations Quality. This role requires a minimum of 3 days onsite per week at our Boston, MA office .
Key Responsibilities: The responsibilities of this role may include, but are not limited to, the following:
Manage Quality staff to collaborate with cross functional technical groups on product stability programs.
QA review of Analytical data in support of Clinical development programs.
Support all analytical related deviations and investigations, OOS, OOTs as applicable. Lead Material Review Board discussions, as necessary
Issuance of Stability reports upon request
Review of RSS and Shipping Excursion Study Reports
Oversee and conduct method validation/ transfer data review, for Clinical reference standard programs.
Review and approve Method Validation and transfer Protocols/reports generated internally and externally.
Support investigations and QA guidance for complex investigations
Communicate any risks and gaps to management as known.
Coordinate with Quality Disposition teams to ensure review and reporting of product release data
Perform Compliance review of data in support of disposition of Clinical product
Resolve issues with CMO or internal technical teams
Support all analytical related deviations and investigations, OOS, OOTs as applicable
Approve Certificate of Analysis
Review and approve stability trend reports in a timely manner
Identify and discuss stability trends with management
Product Transition to Commercial / Registration to Validation / PAI Readiness
Evaluate CMO Quality Systems to ensure compliance with commercial expectations
Provide onsite support for critical batches
Test Articles Oversight
Review of Test Article production records
Review of Test article data
Approval of Test article C of A
Change Controls- execution
Owner /Assessor of Change controls
QA Approver work with technical teams to resolve gaps and approve change plans and classification
Supporting deployment of QMS (GMP Rep)
Generate Performance updates for presentation to QMT, QLT, EQLT as needed
Gap/Risk communication
Metric analysis
Participate on process improvement initiatives
Performance Management/ Individual Development/ Training
Goals development
Perform performance reviews
Create Individual Development Plans in conjunction with employee
Timely completion of training requirements prior to execution
Minimum qualifications:
Master’s degree and 5-8 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background
Successful people management
Previous experience with product stability programs
Preferred Qualifications :
Analytical Experience preferred: Data review, deviation review, change control experience, and Quality System background helpful.
Demonstrate adaptability; think analytically with ability to conduct data analysis while paying attention to details
Broad GxP Knowledge with ability to communicate effectively, collaborate and think critically to support impact assessments
Ability to understand technical processes, Knowledge and application of risk management principles/ Risk Impact evaluation-aligning effort to level of risk
Facilitation/ Problem Solving /organizational, planning, etc./ RCA tools/methodology/…