Associate Director, GMP Quality - Cell & Gene Therapy

Company: Proclinical Group
Location: Boston
Posted on: April 10, 2021

Job Description:

You are here: Home > Associate Director, GMP Quality - Cell & Gene Therapy Associate Director, GMP Quality - Cell & Gene Therapy

• Job type: Permanent
• Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) 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 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. An exciting vacancy has arisen for a Quality Expert, working Medical Device Software Proclinical is currently recruiting for a Pharmaceutical Chemist for an exciting and rapidly growing biotech company in Maryland. This is a contracted role in Switzerland, for a talented Quality Engineer to collaborate with suppliers to obtain details for manufacturing process information We are in search of a Quality Expert Medical Device Software to support, review and maintenance of assigned processes of the Quality Management System Proclinical is currently recruiting for a Senior QA Specialist for a busy, non-profit, biotechnology company located in Rockville, MD. Proclinical is currently recruiting for a QA Project Support Lead for a leading biopharmaceutical company located in Raritan, NJ. Proclinical is currently recruiting for a QA Investigations Lead with a pharmaceutical company located in Raritan, NJ. Our client, a leading biopharmaceutical company, is currently searching for a remote Clinical Quality Specialist. Proclinical is urgently recruiting for a remote Quality Assurance Specialist of Analytics to join our client's Quality Assurance Operations team. Proclinical is working with a biotech company that promotes improved health globally by commercializing innovative vaccines to prevent serious infectious diseases.

Keywords: Proclinical Group, Boston , Associate Director, GMP Quality - Cell & Gene Therapy, Executive , Boston, Massachusetts