Position: Mid-Senior level

Job type: Full-time

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Job content

Role and Company Overview

This role can be based in the U.S. in our Waltham, MA; Greater NYC Area; or King of Prussia, PA locations or in Zug, Switzerland.

We are currently searching for a QA Systems Manager / Senior Managerwho will ensure that the Quality Management System operates in compliance with Good Manufacturing Practice (GMP) along with effectively and efficiently supporting business processes and is inspection ready.

Founded in 2011, Covis Pharma is a private equity backed global specialty pharmaceutical company that markets therapeutic solutions in 50+ countries, for patients with life-threatening conditions and chronic illnesses. Our paramount concern is patient’s outcomes as we focus on improving the health of people with serious medical conditions. Apollo Global Management is the private equity sponsor of Covis Pharma.

If you are looking to be a part of a global, vibrant, and fast-growing organization, have a positive attitude, seeking career development and acceleration and are energized by being a part of improving the lives of the patient’s we serve, we are the perfect match for you.

WHAT YOU CAN EXPECT TO DO IN THE ROLE:

Reporting to the Director QA Systems you will work across all Covis Pharma functions (Supply Chain, Regulatory Affairs, Pharmacovigilance, etc) to support and ensure that all applicable internal Quality Standards/Policies and legislative requirements are maintained. You will support daily operation of Quality System (QMS) as well as the identification of gaps/risks and opportunities for continuous improvement of the QMS and work on their remediation and implementation respectively. You manage and improve the QA Documentation System and Training System for GxP related functions. You will act as business process owner for main QA processes such as change control and complaint management. Lastly you will support compliant operation and change management of GxP relevant computerized systems.

FOR THIS ROLE YOU WILL NEED:

  • A minimum of a BS in pharmaceutical, science or related field
  • Previous GMP QA experience, we prefer over 5+ years.
  • Previous experience with management of QMS preferred, especially eQMS and computerized system validation (CSV).
  • Fluency in the English language is mandatory, German is an advantage

OUR OFFER TO YOU:

By joining Covis Pharma you will be a part of a dynamic and energized team with a vested interest in your personal and professional development. You will be able to provide input into impactful decisions and be a part of shaping our company’s future. The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us. We offer opportunities for advancement and support this through multiple development channels.

Our inclusive company culture brings unique perspectives and embraces diversity of thought. We actively seek to hire and develop the best and brightest team members from all backgrounds ensuring our continued success into the future.

GET TO KNOW US:

Find out more about Covis Pharma by visiting www.covispharma.com

Find out more about Apollo Global Management by visiting www.apollo.com

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Deadline: 10-05-2024

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