Quality Compliance Manager

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About the job

Do you have a Bachelor’s Degree in pharmacy, life sciences, or an engineering discipline? Are you looking for an exciting new career opportunity?

Invenia Group has partnered with a world-leading pharmaceutical company focusing on generics manufacture and distribution. The company is looking for a Quality Compliance Manager to oversee daily operations and projects, providing internal and external GMP Quality oversight of the quality management system, audits, deviations, CAPAs, and change control.

This is a fantastic opportunity to join a top-performing company and expand your market outreach on a global scale – our client is present in over 125 countries!

Role responsibilities: 

If successful, you will be responsible for ensuring global and regional compliance with site processes, as well as the maintenance of the Quality Management System (QMS) implementation and support of the operations’ functions keeping to GMP/GDP standards during the paper to electronic information transfer. You will also be responsible for the following:

  • Performance of validations and qualifications
  • Participation in oversight of vendor activities whilst partnering with third-party key contacts to succeed in QMS outcomes and ensure product quality – batch records, deviation investigations, change controls, annual product reviews, and product dispositions
  • Help in internal audits – working on plans and reports- and subsequently review and evaluate these whilst ensuring compliance
  • Creation and maintenance of the company’s Quality standards and policy to ensure compliance
  • Regional monitoring and tracking of quality metrics

What we are looking for: 

We are looking for someone with a Bachelor’s Degree in pharmacy, life sciences, or an engineering discipline, as well as great working knowledge and experience of GMPs, FDA, EU, and other regulatory agency requirements relevant to quality and compliance. You should have previous experience in a technical, regulatory, or QA role working with APIs, biopharmaceuticals, sterile manufacturing, or QC lab experience, as well as the following skills:

  • QMS application in manufacturing, warehousing, and distribution
  • Ability to utilize quality and risk-management principles and tools
  • Understanding of regulatory requirements – including biological products and facility licensing requirements
  • Ability to travel 25% of the time – including internationally

If you are interested in proceeding with this opportunity, please apply to find out more.