Senior Manager Quality, EM&S Gen Med North America

About The Job

This role reports to the Senior Director, Quality, EM&S Gen Med NA and is part of a team that has primary responsibility for providing quality oversight for 3rd party subcontractors such as CMOs, suppliers, and contract labs, to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs) and Quality Management System (QMS).

Responsibilities

• Ensures the Quality and Regulatory compliance of products subcontracted to external entities on behalf of Sanofi in accordance with cGMPs and Sanofi Quality directives.
• Ensures the efficiency of Quality System implemented between Sanofi and the sub-contractors ensuring relevant management for complaints, deviations, change controls, non-conformities, or any activity aiming to ensure the production, the control, and the release/disposition of products accordingly with Quality, regulatory, and procedural requirements.
• Strengthens the Quality and Regulatory strategy particularly during crisis management and verify the implementation of the relevant action plans.
• Supports the External Manufacturing North America Audit program by working with and conducting contractor audits to assure compliance with Sanofi Quality Directives, current Good Manufacturing Practices (cGMPs), and regulatory filings.
• Leads or participates in the subcontractors audits and managers the CAPAs that follow.
• Supports and manages projects assigned such as new product launch, onboarding/offboarding or subcontractors and products.
• Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filing, or other risks to Sanofi products.
• Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors.
• Participates with subcontractors to find solutions concerning quality issues.
• Respond to customer complaints, including close out and determination of corrective actions.
• Identify and prevent or resolve issues that could impact the continuity of supply of existing products.
• Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations.
• Regular and frequent contact with vendors through formal meetings (systematic business review meetings) or informally when issues cannot wait.
• Constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality.
• Regular contact with Legal to ensure compliance with the activity to all laws and in preparation of Quality Agreements.
• Collaborate with numerous countries affiliates.
• Decision making for quality and compliance issues including but not limited to the disposition of changes, deviations qualifications/validation approval of investigations and assist in the decisions to inform regulatory agencies on issued.
• Escalate non-routine matters to management.
• Solve problems by working with quality and technical counterparts at external manufacturing sites as well as the technical/analytical team internally.

About You

• Bachelor's degree in a Science field.
• 3+ years of experience in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
• Open to domestic and international travel (25-30% of time).
• Co-op or internship experience will be considered.
• Excellent oral and written communication skills in cGMP documentation.
• Experience in third party manufacturing Quality and Regulatory function and/or same plat experience.
• Interpersonal skills to interface with suppliers and customers to develop privileged communications and relationships.
• Excellent teamwork and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects.
• EFFECTIVELY COMMUNICATE AT ALL LEVELS OF ASSOCIATES IN THE SANOFI ORGANIZATION (FROM OPERATOR TO VICE PRESIDENT) OR SUPPLIER AND CUSTOMER AT ALL LEVELS.
• The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries, especially those related to handling product complaints and the associated regulations.
• THOROUGH KNOWLEDGE OF GMP'S AND REGULATORY REQUIREMENTS.
• UNDERSTANDING OF VARIOUS DRUG PRODUCT MANUFACTURING INCLUDING ORAL DOSAGES, SEMISOLIDS, LIQUIDS, INJECTABLES, LYOFOILIZED AND MEDICAL DRUG/DEVICE COMBINATIONS.
• PROJECT MANAGEMENT SKILLS.
• KNOWLEDGE OF FRENCH TO EFFECTIVELY INTERFACE WITH HEADQUARTERS.

Basic Qualifications

• Bachelor's degree in a Science field.
• 3+ years of experience in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
• Open to domestic and international travel (25-30% of time).
• Co-op or internship experience will be considered.

Preferred Qualifications

• Excellent oral and written communication skills in cGMP documentation.
• Experience in third party manufacturing Quality and Regulatory function and/or same plat experience.
• Interpersonal skills to interface with suppliers and customers to develop privileged communications and relationships.
• Excellent teamwork and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects.
• EFFECTIVELY COMMUNICATE AT ALL LEVELS OF ASSOCIATES IN THE SANOFI ORGANIZATION (FROM OPERATOR TO VICE PRESIDENT) OR SUPPLIER AND CUSTOMER AT ALL LEVELS.
• The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries, especially those related to handling product complaints and the associated regulations.
• THOROUGH KNOWLEDGE OF GMP'S AND REGULATORY REQUIREMENTS.
• UNDERSTANDING OF VARIOUS DRUG PRODUCT MANUFACTURING INCLUDING ORAL DOSAGES, SEMISOLIDS, LIQUIDS, INJECTABLES, LYOFOILIZED AND MEDICAL DRUG/DEVICE COMBINATIONS.
• PROJECT MANAGEMENT SKILLS.
• KNOWLEDGE OF FRENCH TO EFFECTIVELY INTERFACE WITH HEADQUARTERS.