Position: Mid-Senior level

Job type: Full-time

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Job content

Role and Company Overview

**To be considered for this role, you will need current work authorization for Switzerland or have current work authorization in the EU.

We are currently searching for a Manager / Senior Manager QA Validation who will be responsible for the oversight of GMP activities at our external Contract Manufacturing Organizations (CMOs) related to validation activities. In this role you will use your strong GMP, technology transfer, CMC, and process engineering background to help actively build the future of our company.

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 Senior Director of QA Operations, you will leverage your extensive knowledge of pharmaceutical manufacturing, cGMP and applicable FDA, EMEA and ICH guidelines to provide technical guidance for all tech transfer activities including trials, validation, registration, and stability activities. You will be responsible to author, review and approve protocols, reports and other documentation. You will be the Subject Matter Expert (SME) for troubleshooting issues, change controls and manufacturing deviations for our CMO network. You will review module 3 CMC records prior to submission to regulatory authorities. You will perform process and equipment gap analysis between sending unit and receiving unit and propose adequate level of verification and validation activities. You will also support analytical method transfers. You will utilize your expertise to drive continuous improvement in all our processes and identify and escalate risks with mitigation strategies or successful project completion. Lastly, you will participate in the selection of new CMO partners.

FOR THIS ROLE YOU WILL NEED:

  • Degreed (Masters or PhD preferred) in pharmacy, chemistry or engineering.
  • Prior experience in the pharmaceutical industry in validation, technology transfer, process engineering, on the floor Quality Assurance or CMC roles. Must have a Quality mindset.
  • Extensive knowledge of cGMP and applicable FDA, EMA and ICH guidance.
  • Prior experience managing CMOs.
  • Prior experience reviewing validation sections of INDs and/or NDAs.
  • Ability to navigate and be successful in a fast‐paced, matrixed work environment.
  • Need to have an entrepreneurial, hands on mind set with the ability to work through ambiguity in a rapidly evolving global organization.

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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