Quality Lead, US Consumer Healthcare

Location: Morristown, NJ

About the Job

Together with the US Country Quality Head, the US CHC Quality Lead is responsible to ensure the implementation and maintenance of the Quality System (covering GxP and health-regulated activities) across the US CHC Commercial organization. This person will ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable US regulatory and GxP regulatory requirements. Also, partner closely/hand-in-hand with the Industrial Affairs Quality Team at the Chattanooga manufacturing & development site.

Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.

• Define, implement, manage and control the CHC US Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements.
• As a US CHC Quality Business Partner, foster quality culture across US CHC, interact closely with Senior Leaders to provide appropriate quality input and agile support to US CHC business.
• CHC US Quality Documentation Management System:
  • Organizing within US CHC a consistent management of Quality Documents related to GxP and health-regulated activities.
  • Implementation of a screening process of released SANOFI/CHC Global Quality Documents and of local regulations to capture the requirements that must be transcribed into US CHC Quality Documents.
  • Provide guidance to CHC Country Functions to develop or update local Quality Documents and related training modules in their respective domains.
• CHC US GxP regulatory inspections:
  • Serve as a key colleague in regulatory inspections in Morristown, NJ (ex. FDA & DEA) related to GxP processes and provide support to and coordination to other GxP Affiliate Functions in regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level (as needed).
  • Where applicable and required by US regulations and/or expectations of the Regulatory Authorities, in coordination with CHC US Regulatory Affairs, lead/co-lead the support of Health Authorities in their inspections of foreign manufacturing sites if/as warranted.
• Be a primary contact for GxP quality system audits performed by Global Quality Audits (GQA) within US CHC and support GQA in their audits preparation, conduct and follow-up.
• Co-lead in defining and implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by US CHC; assure the coordination of the execution of the audits managed at US CHC level.
• Ensure completion of the annual US CHC Affiliate Country Quality Review, including quality oversight on activities executed by US CHC GxP and health-regulated Functions, and monitor the progress status of the defined US Quality program actions.
• Ensure completion a process to manage deviations & CAPAs related to all GxP and health-regulated activities (including those related to audits & inspection observations) and ensure appropriate training of the affiliate personnel in scope.
• Ensure completion across the US CHC a process to manage the changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary.
• Ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved on selection process, qualification and performance of audits) or through coordination with the concerned US CHC functions, as appropriate.
• Ensure that quality risks are properly managed across US CHC and escalate quality events occurring within US CHC according to defined processes and standards.
• Manage CHC products quality complaints (via external contractor) received by US CHC and perform trend analysis.
• Coordinate CHC product batch recalls and ensure prompt execution of recall operations in coordination with other functions within US CHC, as per CHC Global Quality recall process.
• Other duties as assigned; particularly as needed by/with the US Country Quality Head's direction

• 10+ years' Quality experience within FDA regulated environment. Consumer Healthcare or Pharma industry preferred
• Strong knowledge in GMP Regulatory Compliance, including Regulatory audits
• Certified Quality Auditor preferred
• Continuous Improvement Management, Quality Risk Analysis, Quality Risk Management
• Strong interpersonal skills and Communication skills with all levels of stakeholders
• Viva Vault and SAP experience

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks' gender-neutral parental leave.