Quality Assurance Engineer (Quality Compliance Support)
Imagine… 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives.
This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.
We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.
Imagine the lives you could transform by joining the Novartis Gene Therapy team.
The Quality Assurance Engineer, is responsible for the design, validation, maintenance and overall compliance of facilities, systems and processes. Additionally the Quality Assurance Engineer is responsible for Quality Compliance support.
- Supports Quality and Compliance, working in collaboration with Engineering, technical functions, Quality Control and outside consultants and contractors to ensure that Novartis Gene Therapies is:
Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP testing of Novartis Gene Therapies 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.
- Provide 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).
- Act as Quality approver on project deliverables.
- Lead change control review board and project governance.
- Work with colleagues on qualification and validation strategy, to ensure successful validation of equipment.
- Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.
- Author and/or approve Standard Operating Procedures in support of project activity and deliverables.
- Support CAPAs and deviations.
- Support internal audits and annual risk assessment.
- Other related duties as assigned.
- B.S. degree, preferably in engineering or equivalent. 6 years of experience in biopharmaceutical based GMP manufacturing operations.
- 3 years of experience in Quality Engineering/Compliance preferred.
- Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
- Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
- Strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections.
- Strong knowledge of CAPAs and deviations.
- Experience with comprehensive audit support of all internal and external audits.
- Experience participating in internal audits, identify findings, driving to resolution and providing closure report.
- Experience with viral gene therapies, cell culture technologies and/or orphan disease indications is a plus.
- Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
- Excellent oral and written communication skills with strong technical writing experience required.
- Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
The level of this position will be based on the final candidate's qualifications.
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Novartis Gene Therapies Benefit Summary:
Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to email@example.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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