Manager Quality Engineer of Aseptic Performance and Monitoring is accountable for ensuring manufacturing practices adhere to both internal and external standards and requirements for continued process lifecycle validation activities including quality oversight for Continued Process Verification (CPV) and Process Monitoring Program. This position provides quality oversight for aseptic equipment design review and evaluation, ensuring compliance to local and regulatory expectations. This position requires licensed facility management to ensure that the routine process monitoring adheres to the Global Quality Directives, Industry Standards (i.e GAMP, ICH, ANNEX), Code of Federal Regulations, and SANOFI site standards. This position requires evaluation to ensure SANOFI adhere to revisions to Industry Standards (i.e GAMP, ICH, ANNEX) and the Code of Federal Regulations.
-Accountable for the Stage 3 Validation Activities (including process monitoring) which includes the review and approval of documentation (Protocols, Datapacks, Reports, Records, and Procedures) to ensure compliance to Global Quality Directives, Industry Standards (i.e GAMP, ICH, ANNEX), Code of Federal Regulations, and SANOFI site standards. Support other APP quality oversight activities as needed.
- Accountable for quality oversight for aseptic process equipment design review.
- Accountable to provide quality compliance leadership supporting multidisciplinary process monitoring teams to support Stage 3/3A of process validation.
- Accountable to provide quality compliance leadership, within the realm of continued process verification (process monitoring), to support daily manufacturing operations, such as Ffast, Deviations, CAPA's, and Change Controls.
- Accountable for ensuring the quality compliance of cGMP, FDA and EU regulatory agency and internal requirements regarding the manufacture, testing, and distribution of Sanofi products, through formal Quality audits, investigations, internal and external regulation inspections, training, and recommendations to procedures.
- Accountable to comply with the Health Safety and Environment (HSE) objectives and regulations, which are developed on a departmental and site basis.
Education and Experience:
- A minimum Bachelors Degree in Engineering, or related field with 2 - 5 years of directly related experience in a cGMP controlled environment with a good understanding of overall business operations knowledge. 1-2 years of expereience in equipment review/design is required. Aseptic manufacturing experience including equipment review and design, experience interacting with regulatory agencies and health authority inspections is prefered.
- Competencies (LEAD model) – key competencies the job holder will be evaluated on (HOW in 9box): This position is measured on Act for Change, Cooperate Transversally, Strive for Results, and Commit to Customers.
- Key technical competencies and soft skills:
-->In-depth knowledge of GMP/GLP/GCP compliance regulations as it pertains to aseptic processing, Environmental Monitoring, and Continued Process Verification programs in a biopharmaceutical manufacturing setting
-->Strong written and oral communications skills
-->Strong analytical and balanced decision making skills
-->Diverse business, quality, and industrial manufacturing knowledge base
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.