Senior Quality Manager, EM&S Gen Med NA - Manufacturing

BioSpace; Framingham (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Sanofi in Framingham, MA is seeking a Senior Manager Quality, EM&S Gen Med NA to oversee QA/QC and compliance activities for third‑party manufacturers and labs. You will partner with manufacturing, regulatory and supply chain teams to ensure cGMP adherence and successful regulatory submissions, while driving continuous improvement across North America operations.

The role emphasizes strong communication, cross‑functional collaboration, and leadership of quality projects, audits, and CAPA

Qualifications

• Bachelor’s degree in a Science field.
• 3+ years experience in Pharmaceutical Operations or Quality Operations with cGMP.
• Willing to travel domestically and internationally (25-30%).
• Co-op or internship experience considered.

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.
• Support 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 manage 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 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.

Skills

cGMP knowledge

Communication skills

Interpersonal skills

Project management

Quality oversight

Education

Bachelor's degree in Science

Job description

Sanofi in Framingham, MA is seeking a Senior Manager Quality, EM&S Gen Med NA to oversee QA/QC and compliance activities for third‑party manufacturers and labs. You will partner with manufacturing, regulatory and supply chain teams to ensure cGMP adherence and successful regulatory submissions, while driving continuous improvement across North America operations.

The role emphasizes strong communication, cross‑functional collaboration, and leadership of quality projects, audits, and CAPA