Associate Director, GMP Quality Compliance (Onsite)

Job Description

The Associate Director – GMP Operations (Compliance) is accountable for quality oversight of QMS system records (deviations, CAPA, and change controls) supporting cell and gene therapy programs throughout clinical and commercial development to commercialization. The Associate Director is an advanced technical resource in the principles and application of quality assurance and compliance, has experience in participating in cross-functional teams working with deviations, Root cause analysis and CAPAs, as well as developing and communicating department QMS metrics and leading internal Tier meetings such as investigation and change control review boards.  

This position reports to the Director, GMP Manufacturing Technical Services - Quality. 

This role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210.  Monday to Friday.

Key Duties and Responsibilities:

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
• Participates in cross-functional teams as an experienced Quality technical resource
• Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls
• Be the Quality triage and impact assessor of investigations/deviations, reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations. 
• Ensures appropriate CAPA actions are identified and addressed. 
• Maintains Quality Metrics to support process improvement activities 
• Proactively identify, assess and mitigate risks and gaps to cross-functional quality systems and technical quality processes. 
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
• Supports audit programs and inspection readiness including assisting in preparation of audit responses for Cell & Gene Audits.
• Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.
• Execute improvements to QA operations processes.
• Participate/ lead Cell & Genetic Program and Quality projects and drive continuous improvement activities. 

Knowledge and Skills:

• Demonstrated experience in Quality/Technical GMP manufacturing operation. 
• Experience successfully leading event investigations, Root Cause Analysis and CAPA.
• In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; Biotech/Cell & Gene GMP regulations and applicability. (e.g. EU, FDA, ICH, USP, etc. or other industry best practices ex. ISPE, WHO, etc.).
• In depth knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Critical Thinking and problem Solving with ability to evaluate quality matters and make decisions utilizing risk based approach.
• Ability to independently influence and effectively communicate with business stakeholders.
• Strong leade