Compliance Manager, Quality

Principia Biopharma, Inc.

Swiftwater, PA

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For this role, Sanofi flexible work guidelines supports, on average, 2 days a week remote working location with the balance spent at the designated site.

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements.

Key accountabilities

  • Ensure a constant state of inspection readiness and that all audit observations are addressed quickly and completely to maintain readiness levels.

  • Complete minor and major incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas. Provide input and guidance to the team conducting the investigation. Make recommendations to department management regarding results of investigation and process improvements, when necessary. Make final recommended batch disposition. Manage the CAPA system to ensure that corrective and preventative actions are made and followed.

  • Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to Upper Management, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are implemented.

  • Provide support to functional areas regarding the Change Control System by providing assessments, work closure, and follow-up. Recommend documentation and supporting data to include in the Change Control Request to ensure that enough information is provided to the Change Control Board so that an informed decision can be made.

  • Provide final signatory review for SOPs, SWIs, and Master Batch Records to ensure compliance with cGMP, regulatory and internal requirements such as company guidelines and approved procedures.

  • Represent QA on key forums and teams to evaluate and provide QA recommendations on products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements for any proposed changes or new information.

CONTEXT OF THE JOB/MAJOR CHALLENGES

  • Interact successfully within the highly energized production and regulatory environments.

  • Interacts regularly with site counterparts relating to manufacturing, testing, disposition, and cold chain documentation. The incumbent must be able to communicate clearly the cGMP requirements.

  • Freedom to act, level of autonomy: The position has a moderate degree of autonomy and is expected to make decisions and interpretations within defined requirements.

DIMENSIONS/SCOPE

  • This position has no direct reports but will directly interact with shop floor technicians and management, as well as assigned teams, to provide quality oversight for the Swiftwater Manufacturing, Testing, and Support Organizations. This position has no budgeting or purchasing authority.

REQUIREMENTS

Education/experience

  • Bachelor's Degree in Science, with 3-5 years experience in a GMP regulated environment.

Certifications

  • Not required, but QA/RA Certification is preferred.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Fully vaccinated, according to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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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.