Director, Quality Assurance
Cambridge, CA, USA | Jounce Therapeutics, Inc.
Industry:Pharmaceutical / Biotech
Job Description:76 people have viewed this job
The Quality Assurance (QA) Director will be responsible for oversight of the company Quality System and leading and managing QA activities in accordance with GxP (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP)) and other applicable laws, regulation, and guidance. The QA Director must be able to interpret regulations as they apply to a given phase of drug development and will be responsible for GLP nonclinical testing, GMP manufacturing/quality control/labeling/release/distribution, and GCP trial activities for Jounce Therapeutics, Inc. and its affiliates and/or contractors. This role will include the identification of GxP risks along with the development of remediation plans and continuous quality improvement initiatives. The QA Director will lead audits and manage health authority inspections.
Essential Functions (Responsibilities):
Maintain a fit-for-purpose Quality Management System across the GxPs in compliance with regulations through management of quality systems and standards.
Effectively interact with internal team and manage all third parties contracted to perform GMP manufacturing activities to ensure full compliance and adherence to timelines.
Perform batch release activities and review reprocessing and rework procedures.
Oversee GLP testing to assure conformance with protocols, SOPs, and GLP regulations.
Audit on-going clinical trials to assure conformance with GCP regulations.
Administer a document management system for QA and regulatory submissions.
Ensure the development and maintenance of GxP SOPs, in accordance with current regulation and practices, and ensure personnel training files are maintained.
Plan and conduct GxP audits and inspection readiness of laboratories, manufacturing sites and clinical investigations to assess compliance with all pertinent regulations and company requirements (inclusive of comprehensive corrective and preventive action development, approval, and execution).
Partner with cross-functional stakeholders for continuous improvement activities, create/revise procedures/practices and specifications, and provide training on quality systems and procedures.
Manage product complaints and investigations for clinical supplies to determine if it relates to a failure to meet specification and, if so, investigate and report to health authorities if appropriate.
Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure.
Serve as subject matter expert, keeping current with GxPs and industry practices, in order to provide organizational support.
Work in a fast-paced environment with many competing and often changing priorities inherent in clinical development programs.
Contribute to the hiring of team members and train and motivate these colleagues to become leaders.
Bachelor’s Degree in a scientific or health-related field (advanced degree highly preferred)
Minimum of 10 years of Quality experience in the biotechnology or pharmaceutical industry
Extensive knowledge of GxP and QA principles, practices, and standards
Experience with health authority GxP inspections and expectations relating to pharmaceutical quality/CMC
Adept at multi-tasking, problem-solving, leading cross-functional teams, and collaborating with third parties
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