Associate Director, GMP Quality - Cell & Gene Therapy
Proclinical is currently recruiting for an Associate Director of GMP Quality for a leading biopharmaceutical company located in Boston, MA. As the Associate Director, you will be responsible for clinical batch disposition.
- Oversight of Aseptic processing, environmental monitoring program, technical transfers between development/GMP and site/site oversight including operator qualification and media run program including review of analytical method qualifications, transfer protocols and lab investigations
- Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions
- Non-conformance/CAPA Management support. Review and approve non-conformance reports. Mentor investigators and approvers on the investigation process and technical writing
- QA oversight of equipment/facility/utility validation and requalification program and validation master plan
- Review protocols, data summaries, reports for stability studies
- Perform risk assessments of new programs for entry into the GMP facility
- Lead the management review of quality compliance and operational KPIs at the manufacturing facility; ensure timely mitigation of unfavorable trends
- Lead and manage complex projects/teams within corporate objectives and project timelines and participates in cross-functional projects in Quality expert and leader role
- Provide strategies to address compliance gaps or determines enhancements to cross-functional quality systems
- Ensures quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
- Ensures quality staff assesses and approves change controls
- Ensures raw material risk assessments are performed per USP/ATMP guidance
Skills and Requirements:
- Bachelor's degree in a scientific or allied health field (or equivalent degree) and 10 years of relevant work experience, or relevant comparable background in Biologics or Cell and Gene Therapy
- Quality Assurance experience implementing and overseeing investigational drug manufacture and aseptic processing GMP operations in a manufacturing facility
- Demonstrated Quality leadership through a partnership approach with manufacturing to enable high quality and compliant product distribution to patients is required
- Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems teams
- Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
- Strong knowledge of current industry trends and the ability to use the latest technologies
- Working knowledge of Aseptic practices and clean room design/operations, auditing techniques.
- Strong leadership skills with the ability to thrive in a high throughput environment
- Ability to lead and manage projects/teams within corporate objectives and project timelines
- Successful in mentoring people managers
- Collaboration / Teamwork / Conflict Management
If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.