Manager Antigen Quality Systems- Vaccines

Job title: Manager Antigen Quality Systems- Vaccines

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.

​In this role, you'll join the Antigen Quality Systems department at our Swiftwater site, working directly with Operations, Quality, and support groups for day-to-day project management of change control, CAPA, internal audit and document processes for the Antigen Platform. This role is key in maintaining compliance in creating and managing change controls and CAPAs for 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:  

• CAPA, CC, Document and Internal Audit point of contact for an assigned area in the Antigen Platform

• Leads a team, composed of a combination of Technicians, Technical Writers, Operations Managers, and Production Support, that is responsible for timely closure of Quality Items and supporting Antigen in keeping in a compliant and audit ready state.

• Facilitates cross-functional interfacing activities with stakeholders in a very positive manner: Quality Control, Manufacturing Technology, Maintenance, Metrology, Sterility Assurance, and Quality Assurance.

• Responsible for facilitating Change Control, CAPA, Document and Internal Audit Processes to assist in the implementation of the appropriate corrective and preventive actions resulting from deviations as well as process improvements from the Antigen Continuous Improvement group.

• Writes, leads, and manages actions and timelines associated with Change Controls and CAPAs

• Serves as the Antigen Quality Systems point of contact for assigned area during internal audits and Building startups

• Supervises technical writer priorities to complete all quality system related action items in a timely manner

• Facilitates resolution of issues and deliverables by leading meetings, positively influencing functional managers, removing obstacles and managing projects and priorities, which are critical to ensuring timelines are met

• Develops and analyzes weekly status and trending reports and monitors and reports progress to Antigen and QA Compliance Management

• Assures that operations are in compliance with Quality Systems, cGMP, CBER, WHO, EP and other regulatory bodies.

• Required to possess and demonstrate excellent interpersonal/communication skills and management by influence skills, flexibility and the ability to lead and participate on teams. 

About You

Basic Qualifications:

• Bachelor’s level degree in Life Sciences or Engineering with experience working within a production department of a pharmaceutical or Biotech Company.

• 2 - 4 years of experience in manufacturing/production and or regulatory department of a pharmaceutical or biotech company

Preferred Qualifications:

• Working knowledge of cGMP's.

• Understanding of cGMPs and manufacturing activities

• Knowledgeable in lean manufacturing concepts and principles.

• Excellent technical writing skills as applied to the generation of Change Controls, CAPAs, Audit Responses and Document Creation

• Good project management and organizational skills.

• Proficient in Microsoft Office (Excel, Project, Word and PowerPoint)

• Strong time management and prioritization skills

• Quality Management Systems (Phenix) – CAPA Implementation Leader experience and CC Leader experience

• Previous Technical Writing experience

• Strong Critical Thinking skills

• Ability to create and maintain open, positive and constructive relationship with support groups

NOTE:  Candidate must be able to work overtime and flexible hours, including weekends.

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 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.

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.

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