Associate Director, Quality - US Consumer Healthcare (Chc)

Associate Director, Quality - US Consumer Healthcare (CHC)

Location: Morristown, NJ

About the Job

If you're driven by a commitment to excellence, adept at regulatory compliance, and skilled in leading teams to ensure the safety and efficacy of our products, we want to hear from you. Join us in our mission to uphold the highest standards of quality and make a positive impact on the lives of consumers worldwide.

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Main Responsibilities:

• Define, implement, manage and control the CHC Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements.

• As a CHC Quality Business Partner, foster quality culture, interact closely with Senior Leaders to provide appropriate quality input and agile support to CHC business.

• 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 Quality Documents.

• Provide guidance to CHC Country Functions to develop or update local Quality Documents and related training modules in their respective domains.

• Serve as a key colleague in regulatory inspections in Morristown, NJ 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, 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 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; assure the coordination of the execution of the audits managed at CHC level.

• Training: Ensuring appropriate training to quality basics/quality matters of the US CHC personnel.

About You

• 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

Why choose us?

• 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.

• You'll grow alongside a talented team motivated by a shared purpose.

• And you'll discover the depth of potential you can unleash when you enter a world-leading environment, expertly designed to support you making a difference.

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.

#GD-SA

#LI-SA

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!