Specialist, Manufacturing Quality Assurance

Responsibilities:

• Provides quality oversight to manufacturing functions including performing area walkthroughs, shop floor batch record review and support, alarm reviews, etc.
• Provides quality oversight for the manufacturing and support of media, buffers, cell expansion, upstream, drug substance and drug product manufactured in-house
• Ensures quality and compliance of clinical and commercial manufacturing process through review and approval of master and issued batch records, SOPs, specifications, shop floor review, area walkthroughs and audits, manufacturing processes,  including but not limited to: regulatory adherence and audit support
• Collaborates with and supports manufacturing and quality teams to ensure that manufacturing process is consistent, compliant, and adheres to cGMP requirements
• Contribute to the key site metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics, reporting to management all necessary information regarding final product release and release to patient
• Perform data collection, trend quality metrics, and communicate required remediation
• Independently lead projects to address quality gaps or drive continuous improvement related to Operations
• Provides quality input and subject matter expertise on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA’s) and critical processing parameters (CPP’s)
• SOPs/Document Management: Approve all instruction sets, specifications, instructions and other Quality Assurance procedures directly related to incoming quality /operations and other cGMP activities
• Deviation/CAPA Management:  Certified approver of deviations, ensures all deviations from established procedures are appropriately documented and investigated to determine and fix root cause

Requirements:

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• B.S. degree preferably in microbiology, chemistry or biochemistry with 3 years relevant experience; or Associates with 5 years of relevant experience in biotech/pharma.
• Experience with viral gene therapies and/or orphan disease indications is a plus.
• Strong knowledge and application of the CFR’s and cGMP’s and have been involved in regulatory inspections.
• Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
• 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.
• Experience leading internal audits, identify findings, drive resolution and provide closure report.
• Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward

The pay range for this position at commencement of employment is expected to be between $97,600 and $146,400 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture