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Form of workQuality Assurance Manager
Location: Chatanooga, TN
Remote Work: No, onsite required.
Job Type: Full time
About the Job
At Sanofi Consumer Healthcare, we have one shared mission - we work passionately, every day, to 'serve healthier, fuller lives' now and for the generations to come.
In order to do so, 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.
Everything we do is centered around people's interests - our consumers, our customers, healthcare professionals, and our employees - across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
Main Responsibilities
Responsible for all Quality Assurance batch record review and release processes. Ensure that the Document Control group performs timely and accurate reviews of Chattanooga site batch records in compliance with all site SOPs and applicable regulatory requirements. Manage the Quality Assurance department project list, including all Quality improvement initiatives. Coordinate and manage the routine CAPA Board meetings.
Role Specific Responsibilities
About You
Education
Experience
Professional Skills
Role Specific Competencies
Special Requirements
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
#GD-SA
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.
Location: Chatanooga, TN
Remote Work: No, onsite required.
Job Type: Full time
About the Job
At Sanofi Consumer Healthcare, we have one shared mission - we work passionately, every day, to 'serve healthier, fuller lives' now and for the generations to come.
In order to do so, 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.
Everything we do is centered around people's interests - our consumers, our customers, healthcare professionals, and our employees - across the world.
We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.
We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.
Main Responsibilities
Responsible for all Quality Assurance batch record review and release processes. Ensure that the Document Control group performs timely and accurate reviews of Chattanooga site batch records in compliance with all site SOPs and applicable regulatory requirements. Manage the Quality Assurance department project list, including all Quality improvement initiatives. Coordinate and manage the routine CAPA Board meetings.
Role Specific Responsibilities
- Manage the QA Document Control group
- Ensure the timely and accurate review and release of all Chattanooga site batch records
- Processing and packaging batch record generation, issuance, and control
- Develop and maintain SOPs for Document Control functions, including but not limited to:
- Batch record generation and issuance
- Batch record review
- Batch release
- Document archiving and retrieval
- SOP generation and control
- Management of all Quality Assurance projects and Quality improvement initiatives; including tracking, trending, assignment of responsibilities, and evaluation of project deliverables
- Perform internal auditing duties, as needed, to support ongoing Quality System compliance activities
- Act as Subject Matter Expert during internal or regulatory inspections for the activities associated with the QA Document Control group
- Establish and maintain Key Performance Indicators and metrics for Quality Systems and provide routine updates for Management Review and Site Quality Review meetings.
About You
Education
- Bachelor's Degree.
Experience
- 5+ years' experience in an FDA regulated industry. Experience with project management required.
Professional Skills
- Strong communication skills, detail oriented, strong computer systems/technical skills, time management.
Role Specific Competencies
- Electronic document management systems, project management, document control.
Special Requirements
- Project Management
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
#GD-SA
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.
