Sanofi US
Job Title:
Manager Quality Validation Location:
Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines and will review and approve validation related studies for assigned areas.
These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.
This position has signatory responsibilities for validation/qualification documents within assigned areas.
Candidates should have some knowledge in biotech manufacturing processes (i.e. viral antigen or formulation production).
Excellent communication skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur such as Manufacturing Technology, Engineering and Regulatory Affairs.
Good interpersonal and influencing skills are important for a candidate’s success in this role.
About You Basic Qualifications:
Bachelor’s degree in Engineering, Science, or related field with 5+ years' experience preferably in a cGMP environment.
Strong knowledge of cGMP regulations and quality standards applicable to pharmaceutical manufacturing.
Proficient in relevant computer systems and software used in validation and quality management (e.g., LIMS, TrackWise, SAP).
Ability to effectively communicate technical information to diverse stakeholders, including technical and non-technical audiences.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or a lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Equal Opportunity & Diversity Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally inclusive and 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; 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.
#GD-SP #LI-SP
#LI-Onsite #vhd
US and Puerto Rico Residents Only
North America Applicants Only
The salary range for this position is:
$74,250.00 - $123,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
#J-18808-Ljbffr
Manager Quality Validation Location:
Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines and will review and approve validation related studies for assigned areas.
These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.
This position has signatory responsibilities for validation/qualification documents within assigned areas.
Candidates should have some knowledge in biotech manufacturing processes (i.e. viral antigen or formulation production).
Excellent communication skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur such as Manufacturing Technology, Engineering and Regulatory Affairs.
Good interpersonal and influencing skills are important for a candidate’s success in this role.
About You Basic Qualifications:
Bachelor’s degree in Engineering, Science, or related field with 5+ years' experience preferably in a cGMP environment.
Strong knowledge of cGMP regulations and quality standards applicable to pharmaceutical manufacturing.
Proficient in relevant computer systems and software used in validation and quality management (e.g., LIMS, TrackWise, SAP).
Ability to effectively communicate technical information to diverse stakeholders, including technical and non-technical audiences.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or a lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
Equal Opportunity & Diversity Statement Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally inclusive and 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; 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.
#GD-SP #LI-SP
#LI-Onsite #vhd
US and Puerto Rico Residents Only
North America Applicants Only
The salary range for this position is:
$74,250.00 - $123,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
#J-18808-Ljbffr