Job Description
Quality Systems Manager
Location: Midlands
Contract Type: Permanent
Salary: £45,000 - £55,000
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Join a leading company dedicated to empowering patients through knowledge, choice, and convenience
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Drive continuous improvement and regulatory compliance in a collaborative team environment
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Manage the quality management system and oversee regulatory inspections and audits
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Competitive salary and benefits package, with opportunities for professional growth and development
Our client, a prominent player in the pharmaceutical industry, is seeking a highly skilled Quality Systems & Compliance Manager to join their team. This is an exciting opportunity for a quality assurance professional to make a significant impact in ensuring the highest standards of regulatory compliance and product quality.
Position Overview
As the Quality Systems & Compliance Manager, you will play a crucial role in protecting the end users of products manufactured in the compounding unit by maintaining an appropriate level of regulatory compliance. You will be responsible for designing, implementing, monitoring, and maintaining the quality management system, ensuring that all procedures are controlled, current, and compliant with regulatory requirements.
Responsibilities
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Maintain an appropriate level of regulatory compliance to protect end users of manufactured products
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Design, implement, monitor, and maintain the quality management system
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Manage licenses related to specials manufacture and oversee Competent Authority inspections and customer audits
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Lead and manage the QA team to deliver its objectives effectively
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Ensure all procedures are controlled, current, and quality records are complete and compliant
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Conduct Quality Management Review meetings and report monthly quality KPIs
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Ensure compliance with regulatory requirements and manage the audit process for the facility
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Provide support to the Quality Department and maintain compliance with Environmental Health & Safety requirements
Requirements
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Proven knowledge of Quality System processes, with working knowledge of current EU and UK GMP requirements preferred
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Experience coordinating Document Control, Internal Audit, CAPA, Non-conformance, and Complaints processes
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Familiarity with Root Cause Analysis techniques desired
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Internal audit experience is a plus
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Excellent supervisory and management skills, strong problem-solving abilities, and meticulous attention to detail
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Degree in a relevant Life Sciences discipline or a minimum of 3 years in quality team facilitation, project management, or quality data analysis
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Experience in a regulated industry such as Pharmaceutical, Medical Device, or Biotechnology
Company Overview
Our client is a leading organisation in the pharmaceutical sector, dedicated to giving patients control of their health through knowledge, choice, convenience, and connection. With a focus on effective end-to-end clinical fulfillment, they drive improved performance, storage, and throughput of medicines while minimizing waste and increasing value across all stages of goods handling and distribution. The company fosters a culture of continuous improvement, teamwork, and high professional standards, creating an environment where employees are motivated to work collaboratively and manage multiple tasks effectively.
How to Apply
If you are a quality assurance professional with a passion for driving regulatory excellence and ensuring the highest standards of product quality, we encourage you to apply for this exciting opportunity. Please submit your CV and a cover letter highlighting your relevant experience and qualifications to chris.carey@chrlifesciences.com.