Associate Director, GMP Quality - Cell & Gene Therapy job in Boston, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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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