Sanofi Group Manager Annual Product Review - Vaccine in Swiftwater, Pennsylvania
*1st shift position*
*Summarizing compliance data*
*High level technical writing- taking a lot of information and putting together a comprehensive report*
The Manager, Annual Product Review is primarily responsible for the management and completion of the Annual Product Reviews for the Swiftwater Site according to the appropriate procedures. The key deliverables of this role are to ensure APRs are completed timely and in compliance with site procedures. The APRs will be utilized as a communication tool for Site Senior Management to evaluate manufacturing processes, specifications, process controls, trends, etc. for continuous improvement and preventive action in order to ensure we maintain the reliability of our vaccines. The Manager, Annual Product Review will assist in process and documentation updates as needed. The Manager, Annual Product Review will also provide support to facilitate the completion of customer complaints during the peak season to ensure the complaints are investigated appropriately and on time and adverse event investigations as needed.
Responsible for the management of each assigned US and Non-US Annual Product Review (APR).
This includes cooperating transversally with various departments that have responsibilities to the APR process across VIA and to ensure that data is supplied on time and is sufficient and compliant with appropriate procedures.
Support Customer Complaint process with facilitating the logging and investigating of customer complaints during the peak season to ensure the complaints are investigated appropriately and on time.
Support the completion of Adverse Event manufacturing investigations.
Complete Document updates and process improvements
This position is responsible for the compilation and completion of approximately 15 Annual Product Reviews and provide support to the management of product complaint investigations and adverse event investigations.
The incumbent must interact successfully within the highly energized production and regulatory environments.
The incumbent interacts regularly with regional counterparts on intersite activities relating to manufacturing, testing, disposition, and cold chain documentation.
The incumbent must be able to communicate clearly the cGMP requirements. Methods of high level communication include both written and verbal format.
HS Diploma/GED with 6-8 years' experience -OR- BS degree with 3-6 years' experience (Biology, Chemistry, or related discipline).
A minimum 3-6 years’ experience in quality operations.
Strong working knowledge of laboratory and manufacturing processes including cGMP in a pharmaceutical environment, previous biologics manufacturing experience desired.
Familiar with 21CFR
Excellent written and verbal communication skills.
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.