Senior Manager Quality, EM&S Gen Med North America
Sanofi
August 22, 2026
On-site
Framingham, MA
$90,000 - $130,000 USD yearly
Operations
Responsibilities:
- Ensure Quality and Regulatory compliance of products subcontracted to external entities (CMOs, suppliers, contract labs) in accordance with cGMPs and Sanofi Quality directives.
- Oversee the Quality System activities between Sanofi and subcontractors for complaints, deviations, change controls, non-conformities, production control, and release/disposition.
- Strengthen Quality/Regulatory strategy during crisis management and verify action-plan implementation.
- Support the External Manufacturing North America audit program; conduct/lead contractor audits and manage resulting CAPAs.
- Support/manage projects (e.g., new product launch, onboarding/offboarding, subcontractors/products).
- Identify and resolve quality issues impacting cGMP compliance, regulatory filings, and product risks.
- Develop/negotiate subcontractors’ Quality Agreements and provide quality advice.
- Respond to customer complaints, including closeout and corrective actions.
- Identify/prevent issues impacting continuity of supply.
- Review/approve validation protocols, Master Documents, significant deviations, and investigations.
- Make quality/compliance decisions (including change dispositions, deviations, qualifications/validation approvals) and escalate non-routine matters.
Qualifications:
- Bachelor’s degree in a Science field.
- 3+ years in Pharmaceutical Operations or Quality Operations applying cGMPs.
- 25–30% domestic/international travel.
- Co-op/internship experience considered.
Preferred skills/experience:
- Strong cGMP documentation communication.
- Third-party manufacturing Quality/Regulatory experience.
- GMP/regulatory expertise, drug product manufacturing knowledge (multiple dosage forms), project management, teamwork/negotiation, technical knowledge for product complaints.
- Knowledge of French.
Benefits (if applicable):
- Health and wellbeing benefits and at least 14 weeks’ gender-neutral parental leave.
- Ensure Quality and Regulatory compliance of products subcontracted to external entities (CMOs, suppliers, contract labs) in accordance with cGMPs and Sanofi Quality directives.
- Oversee the Quality System activities between Sanofi and subcontractors for complaints, deviations, change controls, non-conformities, production control, and release/disposition.
- Strengthen Quality/Regulatory strategy during crisis management and verify action-plan implementation.
- Support the External Manufacturing North America audit program; conduct/lead contractor audits and manage resulting CAPAs.
- Support/manage projects (e.g., new product launch, onboarding/offboarding, subcontractors/products).
- Identify and resolve quality issues impacting cGMP compliance, regulatory filings, and product risks.
- Develop/negotiate subcontractors’ Quality Agreements and provide quality advice.
- Respond to customer complaints, including closeout and corrective actions.
- Identify/prevent issues impacting continuity of supply.
- Review/approve validation protocols, Master Documents, significant deviations, and investigations.
- Make quality/compliance decisions (including change dispositions, deviations, qualifications/validation approvals) and escalate non-routine matters.
Qualifications:
- Bachelor’s degree in a Science field.
- 3+ years in Pharmaceutical Operations or Quality Operations applying cGMPs.
- 25–30% domestic/international travel.
- Co-op/internship experience considered.
Preferred skills/experience:
- Strong cGMP documentation communication.
- Third-party manufacturing Quality/Regulatory experience.
- GMP/regulatory expertise, drug product manufacturing knowledge (multiple dosage forms), project management, teamwork/negotiation, technical knowledge for product complaints.
- Knowledge of French.
Benefits (if applicable):
- Health and wellbeing benefits and at least 14 weeks’ gender-neutral parental leave.