NCBiotech
Overview
The Senior Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at Novartis Gene Therapies in Durham, NC.
Location Durham, NC – hybrid schedule.
Key Responsibilities
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 guarantee GMP compliance, product safety, effectiveness and intended design goals.
Provides strategic quality input on the translation of commercial product requirements into technical solutions that meet defined CQAs and CPPs.
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.
Essential 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.
Compensation The salary range for this position is $103,600 to $192,400 annually, reviewed periodically based on skills and experience.
Benefits US‑based employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and generous time off.
EEO Statement 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 to perform the essential functions of a position, please send an e‑mail to tas.nacomms@novartis.com or 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.
#J-18808-Ljbffr
Location Durham, NC – hybrid schedule.
Key Responsibilities
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 guarantee GMP compliance, product safety, effectiveness and intended design goals.
Provides strategic quality input on the translation of commercial product requirements into technical solutions that meet defined CQAs and CPPs.
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.
Essential 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.
Compensation The salary range for this position is $103,600 to $192,400 annually, reviewed periodically based on skills and experience.
Benefits US‑based employees receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and generous time off.
EEO Statement 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 to perform the essential functions of a position, please send an e‑mail to tas.nacomms@novartis.com or 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.
#J-18808-Ljbffr