This Quality position ensures Quality Compliance oversight with cGMP, Regulatory and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the floor presence. Quality oversight involves, but is not limited to: auditing of manufacturing areas for compliance, deviation support, documentation support, trending, risk assessments, adherence to the program as documented. The Product Quality Manager QA will perform review of batch records, batch release, handle Product Technical Complaints, QA oversight of deviations, assist in investigations, in raw material release, Annual Product Reports, LRP submission, and Final Release.
QA Primary responsibilities
· Review QC Test data to assure compliance with filed specifications.
· LRP generation and submission
· Review, Approve, and Close Phenix investigations
· Approve and Close Change Controls
· Approval to Formulate
· Release Monovalent Drug Substance batches
· Release Quadrivalent Drug Product lots
· Authorize shipments from Third Party, Sanofi, and Affiliate sites
· Product Technical Complaints
· Annual Product Review
· Review and Approval of SOPs, MBR, Protocols and Reports
· Raw Material Release
· Batch Record Review
· Provide Approval to Formulate to allow formulation
· Review and Approve site SOPs, Deviations and Batch Records
· Review, Approve, and Close Change Control
· Provide Approvals to Pack Bulk
Additional functions assigned
· Perform special projects as assigned by Deputy Director Product Quality
· Adjunct to Deputy Director
· Assist in audit – QA representation assistance with documents, scribe, or runner
· A Bachelor degree, preferably in Science or Life Sciences, with 3+ years in a cGMP controlled/ pharmaceutical industry, preferably in a regulated Quality environment.
Competencies / Skills:
· The ability to understand complex data
· Strong attention to detail
· Experience in technical writing
· Excellent communication/interpersonal skills
· Excellent organizational and teamwork abilities
· Thorough knowledge of cGMPs.
· An Advanced degree in Science AND 3+ years Quality experience in a cGMP controlled pharmaceutical environment
· Experience in Geode, Word, Excel preferred.
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.