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.

Job Responsibilities:

• 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 m.phelan@proclinical.com.

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.

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