Associate Director (Qualified Person)

Job Description

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.

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

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

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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