Senior Quality Assurance Engineer

Major accountabilities:

• Provides QE expertise to support clinical and commercial gene therapy products. Full audit support of all internal and external audits in support of product manufacturing.
• Ensures Quality and Compliance aspects of design and work in collaboration with Engineering, technical functions, Manufacturing Operations to ensure that the facility is:
  • Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing.
  • Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.
  • Capable to meet intended design goals of output volume, turnaround time and operating and product costs.
• Provides strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).
• Acts as Quality approver on project deliverables, as defined in the project plan.
• Works with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Plays a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.
• Authors and/or approves Standard Operating Procedures in support of project activity and deliverables.
• Provides QA oversight of engineering, validation, and facilities activities related to maintaining a GMP facility in a validated state.
• Acts as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing facility in a GMP state.
• Other related duties as assigned.
• Must be able to travel to the Durham, N.C. site for board of health audits as needed.

Minimum Requirements:

• B.S. degree in preferably engineering, chemistry or biochemistry.
• 5 years of experience in biopharmaceutical based GMP manufacturing operations.
• Experience with viral gene therapies, cell culture technologies and/or orphan disease indications is a plus.
• Strong knowledge and application of the CFR’s and cGMPss.
• Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
• Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
• Experience with deviations, CAPAs, and Change Controls.
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
• Excellent oral and written communication skills with strong technical writing experience required.
• Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.

Languages :

• English.