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Director of Quality

Charles River Laboratories International Inc (CRL)

Keele, STS, GB

At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. 

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. 

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

Job Summary

Reporting to the Senior Director of Regulatory Compliance the Director of Quality will be responsible for the Keele and Alderley Park quality groups, ensuring that the operational activities are GMP complaint within the applicable MHRA guidelines and activities are coordinated to meet customer deliverables alongside the Operations and commercial groups.

The Director of Quality will lead on all GMP related matters for the GMP compliant site at Keele as well as the Alderley Park site operating within the principles of GMP and contribute to corporate quality initiatives to improve the Quality programs. the successful candidate will also be the prime point of contact with customers with respect to GMP and quality matters.

Profile and Requirements

Main duties will include:-

  • Leadership on the Quality Forum
  • Communicate all identified compliance and quality risks 
  • Contribute to the strategic development of the site according to Managment initiatives
  • Assuring cohesive approach to regulatory compliance
  • Ensuring the site operates to GMP, ensuring that MHRA compliance is maintained in accordance with the relevant European and where necessary international guidelines
  • Ensuring the sister site operates to principles of GMP procedures.
  • Work closely with Operations and Project Managment to ensure that scheduling of work within Quality Group supports project timelines
  • Assure that Corporate Quality and Compliance policies are implemented and administered at both sites
  • Ensure both sites have an appropriate internal auditing program
  • Work closely in cooperation with other departments to optimize processes, help solve problems and assure quality
  • Co-ordinate / host Client and Regulatory audits
  • Manage the Manufacturing License with responsibility for ensuring that the respective regulatory requirements for batch release and certification are met
  • Drive the generation of audit responses and the implementation of  timely corrective actions
  • Approve a range of quality documents or delegate these approvals to a suitably qualified member of the Quality group

You will have extensive experience in a similar quality leadership role and demonstrate a proven track record of managing multi-disciplinary teams and planning, executing deliverbles within budget and to timescale.

The role will include regular travel between Keele and Alderley Park sites

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

About Corporate Functions  The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.

About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

Job posted: 2023-03-30

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