VP – Head of Quality Assurance
Cambridge, MA, USA | Black Diamond Therapeutics
Industry:Pharmaceutical / Biotech
Job Description:86 people have viewed this job
The VP - Head of Quality Assurance is responsible for the strengthening and further development and execution of the Company’s quality assurance program and systems, in support of all drug development and manufacturing activities, directing cGxP quality related activities across the organization to support global regulatory submissions (NDA/MAA, etc) and ultimately commercial launch of products. The VP will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters. This position requires expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), and Good Laboratory Practices (GLP) and relevant regulations.
Ensure that our Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
Ensure quality metrics comply with best industry standards and practices.
Maintain an effective Quality governance and continually improve governance to meet business and compliance needs.
Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
Ensure products manufactured at CDMOs meet company quality standards and government regulations.
Counsel, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance.
Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
Continually establish and improve quality systems, initiatives, priorities and timelines.
Establish strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements with these CDMOs.
Serve as an escalation point for corporate quality issues.
Responsible for supplier/vendor qualification audit and inspection management.
Serve as primary contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency.
Conduct all duties in compliance with country specific regulations, applicable SOPs, and other applicable guidelines.
Bachelor's degree or Master's degree in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech or Pharmaceutical industry.
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