Auditor Site Quality Operations - Genomics Medicine Unit
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Position Title: Auditor Site Quality Operations - Genomics Medicine Unit
Who You Are
You are a dynamic Quality Auditor interested in challenging the status quo to ensure seamless delivery of cell and gene therapies to our patients. You are a valued influencer who has contributed to an organization to meet unmet medical needs. You have a keen eye for improvement opportunities and the demonstrated ability to deliver on these opportunities using your knowledge of compliance and FDA/EU regulations.
Sanofi’s Genomic Medicine Unit (GMU) CMC group is dedicated to the establishment of best in class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lentiviral vectors, and cell therapy products. Site Quality Operations supports the delivery of these products to our patients.
The primary accountability of this role is to execute Sanofi’s cell therapy manufacturing strategy and be responsible to support the cell therapy clinical manufacturing suite in Framingham, MA. We are looking for a candidate with excellent GMP, scientific, technical, communication, and leadership skills.
- Perform review of Batch records and associated documents in support of release of product.
- Review of Analytical data
- Participate or lead in investigation of all lot-associated deviations, risk assessments and change controls.
- Perform QA presence on the floor/person in plant
- Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies.
- Draft and revise procedures as required.
- Perform internal and external audits for the site.
- Assist in the development of Quality Technical Agreements (QTA) with CDMOs and suppliers.
- Performs work that requires decision making and the consistent exercise of independent judgment and discretion.
- Review and approve Validation protocols and technical reports as appropriate.
- Bachelor’s Degree and 3+ years experience in a GMP environment
- Master's Degree and 1+ years of experience in a GMP environment
- Ability to gown and enter clean rooms
- Excellent communications skills both written and verbal.
- Experience in Cell and Gene Therapy
- Strong critical thinking ability. Strong leadership ability.
- Effective time management and organizational skills.
- Strong attention to detail and ability to lead others in a team setting.
- Experience with CDMOs
The Fine Print:
- Approximately 10% travel for site visits and audits.
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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