Associate Director

2 weeks ago

London, United Kingdom MSD Full time

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

The Global Development Quality team is an established team that supports batch release activities for our company’s Clinical Trials programs worldwide for our company’s Research Laboratories division. We are looking to recruit an **Associate Director, Qualified Person (QP)** to be named on the London Investigational Medicinal Products (IMP) Licence supporting the release of clinical trials supplies. This is a permanent role reporting to the Director of Quality Assurance.

Working alongside other Quality colleagues and QP's, the QP will be involved in the review and certification of batches intended for use in clinical trials, to ensure compliance with EU and UK Good Manufacturing Practice, the Product Specification File and the Clinical Trial Application. This will encompass product manufactured across our company’s Global Supply Chain and subsequently imported into the UK or manufacturing steps occurring within the UK at our Contract Manufacturing Operations. Products include Small Molecules, Large Molecules - Biologics, Vaccines, Gene Therapy etc

The QP will be involved with Health Authority Inspections to maintain the site licences, audits both internal and external, as well as ongoing compliance activities related to clinical trials, for example technical and quality agreements with collaborators, stock recovery activities etc.

We offer in-depth onboarding and training support to fully integrate our new QP into the role within our Global Development Quality team, setting you up for success in your new role.

This role is based at our Central London office with hybrid working available.

**Qualifications and Experience**:

- Eligible to be named as a Qualified Person (QP) and to have maintained Continued Professional Development CPD
- Extensive experience in a cGMP environment, preferably gained in a Quality function with respect to clinical trials/IMP environment
- Experience with conducting audits and hosting inspections
- Dynamic individual with excellent organizational skills, who can work effectively and proactively on global functional teams
- Effective verbal and written communication skills in collaborating to colleagues and associates both inside and outside the organization

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
Domestic

**VISA Sponsorship**:
No

**Travel Requirements**:
10%

**Flexible Work Arrangements**:
Not Specified

**Shift**:
Not Indicated

**Valid Driving License**:
No

**Hazardous Material(s)**:
n/a
**Requisition ID**:R278335

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