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Quality Assurance Manager

Company: Principia Biopharma Inc.
Location: Framingham
Posted on: June 6, 2021

Job Description:

We at Kiadis Pharma, a Sanofi Company are focusing our research & development on NK cell therapeutics, leveraging the natural strengths of our immune systems to source the best cells for life.

Are you a quality assurance expert that has a track record of GMP projects and is ready to deliver crucial input? Are you a strong communicator, charismatic influencer and able to effectively manage leadership encounters with a high sense of integrity? Are you interested in working remotely and based in the Boston area (or willing to relocate)? Read-on.

The role

As a QA Manager you will be responsible for the coordination of quality operations of both in-house and outsourced manufacturing and ensure that the production and quality control activities are performed in compliance with GMP/GDP requirements. The scope of the role includes oversight of in-house manufacturing, CMO manufacturing and QC release testing laboratories operations. In your day-to-day you will:

  • Ensure the production and control activities performed at Kiadis manufacturing and testing locations are in compliance with GMP requirements and quality agreements.

  • Participate in regulatory inspections at Kiadis manufacturing and testing locations as required.

  • Perform audits of the Kiadis suppliers and service providers as required.

  • Lead effort in continuous improvement of GMP compliance.

  • Provide guidance and support to Kiadis manufacturing and testing staff concerning compliance with relevant quality and regulatory policies and the development of strategies to improve quality working practices and systems.

  • Build cross functional relationships to support Quality Operations throughout Kiadis organization and at CMO or testing laboratories.

The ideal candidate

We are looking for someone that shares our love for cells, and likes being part of a dynamic organization. It would be great if you have the following requirements:

  • University degree in biomedical and/or life sciences.

  • Minimum of 8 years of QA Pharmaceutical/biotechnology experience.

  • In depth experience with Quality Systems and Quality Management programs.

  • In depth knowledge of EU & FDA regulatory agencies expectations.

  • Experience overseeing contract manufacturing and testing vendors.

  • Knowledge and experience in international GMP and regulation inspections.

  • Excellent communication skills, both oral and written.

What we offer

People from all over the world, together as one team, contribute to improving the lives of patients every day. We offer an exciting position in an innovative, dynamic and inspiring environment where you'll receive a competitive remuneration package, autonomy and the opportunity to make your own mark within Kiadis.

We create an environment where ideas are shared, experiences are impactful, and talent is developed. Because of our inclusive and family-like environment, you will always have the feeling of belonging & appreciation.

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.

Keywords: Principia Biopharma Inc., Framingham , Quality Assurance Manager, Other , Framingham, Massachusetts

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