Sanofi Group Manager, Supplier Quality and Audit Management in Chattanooga, Tennessee
Manager, Supplier Quality and Audit Management
Sanofi Consumer Healthcare US (formerly Chattem) is a leading marketer and manufacturer of a broad portfolio of branded over-the-counter (OTC) healthcare products, in such categories as allergy, upper and lower gastrointestinal, skin care, topical pain care, oral care and other OTC toiletry products. The US CHC portfolio includes well-recognized brands such as: Allegra, Nasacort, Xyzal, Dulcolax, Gold Bond, Cortizone-10, Icy Hot, Aspercreme, Rolaids, ACT, Unisom, and Selsun Blue.
Manage the GMP Self-Inspection Program and External Audit Program of Contract Manufacturing Organizations (CMO), material suppliers, and service providers to support the Chattanooga CHC site. Oversee and support the External Manufacturing Quality Assurance group. Represent Chattanooga on Supplier Quality Initiatives within Sanofi. Generate and report on audit and EM quality metrics during quarterly Management Review meetings.
Role Specific Responsibilities
Management of CMOs and suppliers including the following:
Oversee and assist with generation and review of Quality Agreements.
Generate performance assessment of CMO's and Suppliers.
Generate risk assessments of CMOs and Suppliers for compliance to cGMPs. Generate the annual Self-Inspection Plan and maintain associated Self-Inspection documentation.
Track and report Self-Inspection metrics on a quarterly basis.
Responsible for accurate and timely execution of the annual External Audit Plan.
Track and report audit metrics on a quarterly basis.
Mentor, train, and provide guidance to less experienced auditors regarding the auditing process.
Assist in resolution of quality issues relating to products produced by CMO’s and suppliers.
Schedule, participate, and monitor progress against corrective actions from audits of: CMO’s. API (active pharmaceutical ingredient) and Excipient site audits.
Contract Laboratories to include safety and clinical studies. Primary and Secondary Packaging suppliers.
Self-Inspection Audits Manage CMO and supplier audit activities and documentation as required within PHENIX database.
Serve as the “key user” for related Quality and External Audit modules in Phenix.
Maintain the annual Approved Supplier List.
Assist with monitoring and recording the completion of corrective actions of Sanofi and regulatory authority audits of the Chattanooga site.
Develop metrics to track the effectiveness of self-inspection and external auditing processes.
All IA departments, Global Quality, and CMOs
Direct Responsibilities: Senior Quality Assurance Auditor, QA Supervisor, External Manufacturing
- Experience with cGMP Quality Systems
This description is representative but not inclusive of all position responsibilities. Associate may be asked from time to time to complete tasks not listed within the contents of this document, but that are relative to the goals of the business.
Education: Bachelor’s degree required; Master’s degree preferred
Experience: Minimum three years' related experience required; five years’ experience in Quality Assurance preferred
Professional Skills: Self-motivated, detail oriented, good organizational skills, computer skills, strong communication skills, and time management skills
Role Specific Competencies: Knowledge of FDA cGMP and QSR regulations required
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.