Associate Director, External Quality Operations

Responsibilities:

• Lead cGMP QA compliance activities at external CxOs for all relevant operations. including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products
• Oversee quality aspects for commissioning, qualification and validation activities for equipment, batch record review, deviation handling and quality event processes at external CxOs
• Support complex external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally, when applicable
• Act as QA representative at internal project meetings and meetings with external CxOs; liaise with external QA representatives and maintain external relationships
• Maintain knowledge of current industry standards and trends in best practices for compliance with cGMP regulations
• Assist in the preparation of regulatory documents, including briefing documents, IND filings, etc.

Minimum Requirements:

• Life Sciences-based MSc or PhD with a minimum of 8 years’ experience in pharma, biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and QA operations in a GMP-regulated environment
• Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy
• Extensive experience working with CxOs and contract testing labs, including negotiating Quality Agreements and resolving quality issues
• Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations
• Knowledge of medical device quality requirements and knowledge of ISO requirements for medical device production and testing is an asset
• Ability to lead teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts
• Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity; skilled with influencing and negotiating with stakeholders of various levels
• Ability and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight)