Senior Director/Head, Quality Assurance 1069386
Job Scope and Purpose:
Our Cambridge based clinical-stage client, who is using a novel class of biologics to engage and modulate T-cells for oncology and autoimmune targets, is seeking a Senior Director, Quality Assurance to lead the quality function. The ideal candidate will build out our clients quality systems, deliver GXP compliance strategies, lead auditing initiatives, and provide quality support for all clinical development programs. A candidate with previous exposure to regulatory filings, or managing regulatory consultants, would be preferred. For more information about this exciting leadership opportunity, please contact Todd Jamison!
Primary Job Responsibilities:
- Develop and lead compliance strategies for GMP, GLP and GCP, while providing quality advice and support for all clinical development programs
- Develop and implement risk mitigation measures, standards, policies and procedures for GXP compliance
- Provide guidance to cross-functional teams to ensure GXP compliance, while serving as a Subject Matter Expert for interpreting GXP and ICH regulatory expectations and requirements
- Oversee the build of internal quality systems
- Contribute to IND, IMPD and CTA regulatory filings
- Plan and oversee all domestic and internal compliance audits for GMP, GLP and GCP to identify compliance risks and determine compliance status, while recommending to management resolution solutions on audit findings and implementing and documenting audit resolutions
- Manage QA review of GMP manufacturing, including batch records, product release, stability testing, validation reports and essential clinical study documents
- Assist in evaluating and selecting contract manufacturing and analytical testing sites, CROs and other service providers critical to supporting ongoing clinical development programs
Primary Job Requirements:
- A relevant degree (BS minimum, advance degree preferred) in a scientific discipline with at least 15 years' QA experience with protein based biologic programs
- Hands-on experience building and managing quality systems for sterile biologics products to support global clinical trials
- Ability to interpret and apply FDA, ICH and GLP regulations, guidelines and best practices
- Experience acting as a regulatory agent to support IND, IMPD, CTA and other regulatory filings is preferred
- Experience in planning and conducting GMP, GLP and GCP audits
- Ability to use a phase appropriate approach to assess product quality and regulatory compliance during the review and disposition process
- Experience developing and maintaining Quality Management Systems such as documentation and record management, change control, deviations, investigations, training and CAPA programs
- Experience reviewing and auditing study-related documentation such as non-clinical and clinical study report, and investigator brochures
- Ability to travel domestically and internationally to vendor and partner sites as needed to support product development activities and corporate partnerships
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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