We are seeking a highly motivated individual to join the BlueRock team as an Associate Director in the Quality Assurance (QA) department reporting to the Sr. Director of External Quality Operations. This position will be responsible for providing QA oversight for cGMP activities at external contract organizations (CxOs) for all relevant operations of aseptically produced investigational cell and gene therapy products. This position will work with a diverse group of internal and external partners to provide a continuously improving, controlled, compliant and effective program.

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)