Associate Director, GMP Quality - Cell & Gene Therapy

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP)
  3. United States
Boston, USA
Posting date: 24 Mar 2021

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

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.