Senior Quality Assurance Engineer

Summary

The Senior Quality Assurance Engineer is responsible for design, construction, validation, maintenance and overall compliance of facilities, systems and processes at Novartis Gene Therapies, Durham, N.C.

Location:

Durham, N.C. Hybrid schedule may be available.

• 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 and 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 of meeting 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.
• Works with supplier and vendor management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements.

• B.S. degree in engineering, chemistry or biochemistry.
• 7 years of experience in biopharmaceutical 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 cGMPs.
• 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.

The salary for this position is expected to range between $103,600 and $192,400 annually. The final salary offered will be determined based on relevant skills and experience, and will be reviewed periodically. Performance-based cash incentives and eligibility for annual equity awards may be offered depending on level. US-based employees receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a generous time‑off package including vacation, personal days, holidays and leaves.

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people who collaborate, support and inspire each other, combining to achieve breakthroughs that change patients’ lives.

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or for performing essential functions of the position, please email [email protected] or call . Include the job requisition number in your communication.