Quality System Lead

Quality Systems Lead

Department: Global Quality Systems

Reports To: Quality Operations Manager

Location: Cambridge

Job type: Permanent

Join us and make a difference when it matters most!

At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees

Role and Responsibilities

Implement and maintain an effective Quality Management System supporting Global Operations in order to:

• Enable the manufacture of medicinal products in accordance with current national and international applicable legislation and regulatory expectations, relevant standards and guidelines and the relevant Manufacturing and Marketing Authorisations.

• Identify and manage risks to the business through application of Quality Risk Management and effective Change Management.

• Ensure Quality Management System remains in a State of Control and opportunities for improvement are continuously identified and acted upon

Governs/supports the global and local Quality Management Systems by maintaining, tracking, and improving the associated documentation and systems to ensure:

• Effective processes and procedures are in place in line with Mundipharma Quality Framework and policies, cGMP and local regulatory requirements

• Continuous improvement opportunities are identified and implemented to maintain and advance Mundipharma’s compliance posture and effective and efficient operations.

Assesses global and local process and product quality performance indicators to monitor whether the pharmaceutical quality system is in a state of control by:

• Undertaking quality data trend analysis by employing data analytic

• Presenting quality data trend analysis at operational and management review forums.

• Co-ordinating the writing of local Annual Product Quality Review reports and ensures appropriate Corrective and/or Preventive Actions are identified as required.

Leads the inspection readiness program to maintain and advance Mundipharma’s compliance posture by 

• Participating in pre-audit, audit execution and audit response activities for internal audits in support of the company self-inspection program

• Maintaining applicable MIA/WDA/API licenses and site master files

• Supporting the hosting of external inspections and customers audits by participating in preaudit, audit execution and audit response activities.

Support the Quality Operations teams to ensure that electronic Computerised systems records are completed in a timely manner and systems; including upgrades are implemented in compliance with regulatory requirements

What you’ll bring

• Experience in a quality related role within the Pharmaceutical Industry or related technical industry

• Extensive practical experience (5+ years) in Quality Management Systems within the Pharmaceutical Industry and/or Medical Devices

• Team management experience

• Experience in a quality related role within the Pharmaceutical Industry or related technical industry

• Extensive practical experience (5+ years) in Quality Management Systems within the Pharmaceutical Industry and/or Medical Devices Knowledge and Skills

• Excellent communication skills (including public presentation and technical report writing skills) and ability to communicate and interact at all levels of the business and externally;

• Ability to motivate and support the wider Mundipharma team to achieve the goals of the department and the overall business

What we offer in return

● Flexible benefits package

● Opportunities for learning & development through our varied programme

● Collaborative, inclusive work environment

Diversity and inclusion

Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.

About Mundipharma

Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit www.mundipharma.com.

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Additional Job Description:

Primary Location:

GB Cambridge

Job Posting Date:

2025-03-03

Job Type:

Permanent