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 Quali... more details
Associate Director, Quality – US Consumer Healthcare (CHC)
- Location: Morristown, NJ
- Remote Work: Hybrid
- Travel Expected: Limited
- Job Type: Full Time
About the Job
At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.
Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.
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 strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.
Our Team:
Together with the US Country Quality Head, the US CHC Quality Lead is responsible to ensure the implementation and maintenance of the CHC US Country 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.
Main Responsibilities:
- 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.
- Training: Ensuring appropriate training to quality basics/quality matters of the US CHC personnel.
- 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 the monitoring and periodic reporting of US CHC Quality KPIs.
- 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.
- Maintain an up-to-date local inventory of GxP computerized systems and GxP spreadsheets in use within the US CHC for GxP and health-regulated activities, and guarantee they are validated by the relevant ITS functions in charge.
- 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.
- Ensure the quality oversight on management of CHC product distribution issues including temperature excursions.
- Other duties as assigned; particularly as needed by/with the US Country Quality Head’s direction
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
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, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
#LI-SA
#LI-CHC
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!
