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Location: Cambridge (Hybrid Working)

Job type: Fixed Term Contract (12-Months)

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.

The person will be accountable for the provision of quality management system (QMS) activities, management and oversight of GxP third party service providers, provision of proficient and scientific quality advice to our internal and external stakeholders and represent quality on the assessment of new business opportunities and introduction of new products into the Mundipharma portfolio. This will enable Mundipharma to expand their portfolio whilst establishing, implementing, and maintaining a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities and other internal and external customers.

Key Responsibilities Management of high risk, wide-ranging and complex third party providers and supply chains to ensure successful new product introductions, GxP compliance, patient safety and reduce risk of market actions (e.g. recall of products) by: Writing new and Updating Technical/Supplier agreements; Ensuring Quality Activities are carried out efficiently and effectively in line with relevant Quality; Agreements with associated Mundipharma Supply Chain and manufacturing entities

Conducting effective Quality Review Meetings

Reviewing Periodic Quality Reviews and stability data

Reviewing of third party Change Control, Deviations, CAPA and Complaints using risk management principles;

Reviewing and generating Supply Chain Maps (where applicable);

Representing Quality on the assessment of new business opportunities via cross functional due diligence processes;

Supporting/conducting site visits;

Working cross-functionally to represent quality on the introduction of new products into the Mundipharma Portfolio;

Timely and effective completing New Product Introduction processes within the Quality Management System;

Be accountable for high complexity internal Quality Management Systems (QMS) activities

Issuance and approval of regular reports on a variety of Supply Cain Assurance areas (e.g. complaints, CMO issues, KPIs, metrics, etc)

Escalation of Significant Quality issues (SQI) to the Manager of the department and leading issue resolution and implementation of risk mitigation

Ensuring compliance with statutory duties, regulation and legislation, including GMDP

In-depth understanding the nature, operation and strategy of the organisation and the network of IAC's and continuously drive for improvement

Qualifications Scientific degree in Pharmacy, Chemistry, Biology, Engineering or aligned working experience.

Certified Lead Auditor (e.g. IRCA certification) is desirable.

Extensive practical experience in Quality roles within the Pharmaceutical Industry or extensive practical experience in Quality Management Systems within the Pharmaceutical Industry and management of third party providers, in depth knowledge of various dosage forms, audit experience.

Full breadth of knowledge and application of Global Good Manufacturing and Distribution Practices (GMDP) and manufacturing process for various dosage forms including complex and high risk.

Full breadth of knowledge and application of processes associated with third party management.

Good knowledge of due diligence and new product introductions for highly complex and high-risk dosage forms and products.

Demonstrated successful competency in the application of risk management principles with the ability to assess risk and provide advice on resolution.

Ability to solve complex problems relating to Quality.

Organisation skills and the ability to multi-task ensuring all customers receive the appropriate level of service to ensure compliance.

Ability to present effectively both internally and externally.

What we offer in return flexible benefits package

opportunities for learning & development

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, as we focus on making a positive difference for our customers and their patients.

About Mundipharma

Mundipharma is a global healthcare company with a presence 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 and Consumer Healthcare as well as other severe debilitating disease areas. Our guiding principles, centered around Integrity and Patients-Centricity, are at the heart of everything we do.

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Additional Job Description:

Primary Location:
GB Cambridge
Job Posting Date:
2024-12-12
Job Type:
Fixed Term Contract (Fixed Term)