Manager Quality Control Compliance - Vaccine
Pearl River, New York, Meriden, Connecticut
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Position Title: Manager Quality Control Compliance
Location: Meriden CT
Who You Are
You are an experienced Quality Assurance manager with a background in QA for QC functions. You have a quality mindset and will provide guidance to department employees in cGMP practices . You will possess a working knowledge of CFR-21 expectations. You are a multitasker with the ability to adapt to changing priorities in line with business needs.
Who We Are
We are a QC organization supporting testing activities for commercial and development (pipe line) projects spanning multiple areas of treatment for Sanofi Biologics. The scope of our activities include all routine QC/Micro testing for Drug Substances, Drug products, In process , raw material and stability samples conducted internally as well as external testing sites.
Where We Are
Meriden is located at the Crossroads of Connecticut, being bisected by two of the State’s major freeways (I95 and (91), Meriden is situated midway between the cities of New Haven and Hartford, located about 20 miles to the north and south, respectively. Train service is available from the State St. station. The City is located within 25 miles of several world-class educational institutions.
Lead and manage compliance activities in Quality Control including Deviations (OOS/OOT), CAPA, Document Control, Product Testing ,Change Controls.
Lead and coordinate departmental commitments for internal and health authority commitments.
Establish and manage compliance program for controls for test related documents in accordance with cGMP requirements.
Manage the departmental training programs and maintain accountability for adhering to training requirements for all departmental personnel.
Serve as the single point of contact for Quality Events and establish close liaisons with Quality Assurance for managing quality/compliance events.
Conduct self-audits including laboratory walk throughs and drive remediations through the area managers.
Assume Ownership in maintaining the QC laboratories in an audit ready status.
Establish KPI’s with the assistance of management team and provide matrices to site quality meetings and other requests.
Serve as a formal/informal reviewer for test method SOP’s ,test protocols, reports for compliance aspects.
Identify and support continuous improvement efforts in the laboratory in collaboration with the QC management.
Serve as a primary participant for QC during Internal and regulatory audits.
BS/MS in Chemistry/Biochemistry/Biology or related discipline with more than 5-6 years of management experience in a cGMP laboratory.
Demonstrated experience in a Quality compliance (QA or QC)
Demonstrated understanding of regulatory expectations in compliance in a QC environment.
An understanding of routine QC operations including testing, Laboratory compliance management, Quality events and Risk assessments.
Good Organizational, verbal and written skills is required. Basic computational skills including Microsoft Word and Excel are required.
Experience with laboratory electronic systems including deviation and documentation systems.
Ability to become familiar with routine test methods as it relates to job function.
Terms of Employment
Approximately 30% travel between the Meriden and Pearl River testing sites.
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.
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