Manager DC Quality Support
This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic
"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."Suncére Hernandez Area Business Manager, Multiple Sclerosis
"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."Bob Shustack Head of Global Support Functions Finance, North America
Essential Job Duties and Responsibilities
- Identify and assist in the resolution of quality related issues at the DC that impact cGMP compliance or present a risk to Sanofi products.
- Act as Primary Contact for site environmental control system; assume responsibility for alarm acknowledgement and investigations. Provide guidance on product temperature excursions and impact on product quality.
- Generate monthly Quality Performance Indicators or other key metrics.
- Provide quality-related training for DC personnel, as required.
- Act as Primary Contact on site Change Controls, Deviations, and Corrective/Preventive Actions.
- Interface with internal / external auditors or with regulatory inspectors at the site level; act as primary host and representative for the site during audits and/or inspections
- Manage / maintain the DC Approved Supplier List; ensure that Quality Agreements are in place with all GxP service providers.
- Maintain a thorough knowledge of distribution processes and procedures.
- Represent DC Quality on corporate quality initiatives. Support and/or lead projects as assigned, such as new product launch teams.
- Identify and assist in the resolution of quality related issues that impact cGMP compliance.
- Monitor, track, and assess the effectiveness of cGMP compliance programs and make adjustments to enhance program effectiveness, as needed.
- Create / Review / Revise new and existing DC SOPs for compliance to cGMP, Sanofi policies, and Global quality documents as required.
Job Related Experience
- Bachelor's degree and/or 5-7 year of experience, specific to QA/QC work in the pharmaceutical industry, with preference for previous experience in cGMP DC environment.
Knowledge, Skills and Equivalent Experience
- 5-7 years management experience (Logistics, Customer Service & Quality Assurance) in the Pharmaceutical industry; Distribution Experience preferred.
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.
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