Senior Supply Chain Quality Assurance Specialist

Senior Supply Chain Quality Assurance Specialist

Location: Cambridge

Department: Quality, Rx (Ethical) Division

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

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.

1.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;
• Ensuring all regulatory required documentation is in place;
• Reviewing Periodic Quality Reviews;
• Reviewing of Stability data;
• Reviewing of third party Change Control, Deviations, CAPA and Complaints using risk management principles;
• Reviewing and generating Supply Chain Maps;
• Participating and working collaboratively with internal and external stakeholders on issue resolution to ensure product quality, compliance and supply;
• Establishing effective partnership and relationship with third parties.

2. Management of new business opportunities by:

• Representing Quality on the assessment of new business opportunities via cross functional due diligence processes;
• Supporting/conducting site visits;
• Generating quality reports to the Board of Directors/Senior Management utilising risk management principles for new business acquisitions;
• Working cross-functionally to represent quality on the introduction of new products into the Mundipharma Portfolio;
• Working cross-functionally to represent quality on the expansion of the Mundipharma footprint for existing products;
• Timely and effective completing New Product Introduction processes within the Quality Management System;
• Negotiating quality terms by implementing new Technical/Supplier agreements
• Assessing business risk and documenting E2E supply chain maps;

3. Be accountable for high complexity internal Quality Management Systems (QMS) activities including but not limited to:

• Deviations;
• Change Control;
• CAPA;
• Complaint;
• Temperature Excursion reports;
• Technical Agreements;
• Issuance and approval of regular reports on a variety of Supply Cain Assurance areas (e.g. complaints, CMO issues, KPIs, metrics, etc);
• Acting as a quality advisor/advocate to ensure tracking and timely closure of internal and external QMS activities utilising Trackwise system;
• Driving Quality Culture and being accountable for specific areas of the QMS as defined by the Manager of department.

4. Lead projects and continuous improvement initiatives within the department, cross functionally and externally, including:

• Implementation/Review of performance metrics to drive continual improvement and reduce risk to the business;
• 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;
• Driving and supporting the process of continuous improvement with the aim to reduce cost, improve quality and increase efficiency;
• Successful tracking of personal development and training needs and contribute to other development plans and annual reviews;
• Coaching and mentoring of others to ensure development of personnel.

5. Pro-actively support and intensive participation (e.g. lead, act as SME) in both internal and external inspections including regulatory bodies.

What you’ll bring

Extensive practical experience (4+ years) in Quality Management Systems within the Pharmaceutical Industry, management of complex supply chains, proficient in various dosage forms including sterile.

Knowledge and skills:

• 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;
• Excellent report writing skills and able to communicate and interact at all levels of the business;
• Ability to apply experience and knowledge in the assessment of new business opportunities;
• 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 contribute to the team's objectives to achieve the goals of the department and overall business;
• Ability to present effectively both internally and externally.

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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