Job Description Summary
This position isresponsible for leading the Quality Operations function at the Durham, NC site and ensuringISO and cGMP compliance and quality oversight for the research cells operations, including the production, testing, release anddistribution of research cells and related materials. This position develops and manages the execution of all Quality Systems related to research products manufacturing and participates in key customer interactions and project teams, Additionally this role may have oversight forother Bioscience Operations within the region
Primary Roles and Responsibilities:
- Manages the Quality Assurance teams and related ISO and GMP quality systems; Hires, trains, coaches and develops staff within Quality team.
- Oversees development and approval of ISO and cGMP documents including, but not limited to, SOPs, Batch records, protocols and specifications.
- Ensures internal audits are conducted of operations on a timely basis; ensures follow-up of audit CAPAs
- Ensures a risk-based supplier quality program is in place and maintained, appropriate for types of products manufactured at the site.
- Ensures all non-conformances, OOS, deviations, complaints and related items are thoroughly investigated and resolved.
- Ensures QA review of all manufacturing and QC related records, resolution of all related issues and QA disposition of product batches to customers.
- Ensures QA review and disposition of raw materials, buffers and other components
- Ensures GMP training program is in place for all staff engaged in GMP activities at the clinical manufacturing site.
- Ensures all initial qualifications, validations, and re-validations are in place for facilities, equipment and processes related to research products manufacturing. Ensures facilities are suitable for products manufactured.
- Acts as Quality and Compliance SME for manufacturing operations. Participates in or ensures Quality unit participation in project teams as required.
- Manages site Quality Council, monitoring of Quality Systems, including tracking of KPIs, and Quality Risk Management program for Bioscience Operations. Ensures escalation of quality issues to Site Quality Head and Regional Head of Quality as appropriate. Ensures report development and management discussion of annual Management Review
- Acts as back-up for other Bioscience Sr. Managers in the network as requested. Act as senior Quality representative on product development teams.
- Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field.
- At least 10 years of relevant experience in the biotech/pharmaceutical industry with proven management experience.
- Working knowledge of ISO and cGMP requirements for research products and biologics manufacturing. Working knowledge of requirements for aseptic manufacturing. Basic knowledge of cell biology, cell culture.
- Ability to effectively develop and lead teams and work collaboratively in matrix organizations and team.
- Ability to interpret ISO and cGMP requirements for research products manufacturing.
- Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.
- Effective communication (verbal and written) skills required.
- Problem solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required.