Job Description

An amazing opportunity has arisen for an Associate Director QC at Dunboyne within the Global Quality Large Molecule Analytical Sciences QC team. As the Quality Control (QC) Lead the overall responsibility for this role will be to manage, plan and direct the Quality Control laboratories to ensure compliant laboratory testing and provide the highest quality analytical support for manufacturing and the wider network, while ensuring compliance with cGMP and safety regulations. This is a critical role within the Site leadership organisation to help create value for our patients.

Dunboyne is a state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.

Key responsibilities will include

Strategic Quality Control oversight and leadership at the Dunboyne Biologics start-up facility to meet functional and site goals and objectives.Responsible for Quality Control related testing for the Dunboyne site (Analytical, Biochemistry, and Raw Materials).Hire, develop, lead and coach the Quality Control team and drive a high performing organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, performance, and budget management. • Build safety as a value within the Quality Control teams and maintain sustainable EHS programmes that are engrained within the department.Responsible for Quality Control oversight and compliance of laboratory related commissioning, qualification, and validation activities.Responsible for developing the QC function into a ‘testing centre of excellence’ to support on site and network testing programs.Responsible for ensuring that the Quality Control laboratory test methods are qualified/validated as per corporate and site procedures.Provides guidance to all relevant quality related events and direction to develop the area(s) technical and compliance capability along with long term strategic planning.Maintains all laboratories in an inspection-ready, GMP-compliant state.Ensures Quality Control-owned business systems are established and engage with the business systems owner to continually improve processes.Leads the Quality Control department in meeting targeted site and Tech Ops quality objectives, ensuring department objectives are aligned, translated to all and visually managed to drive delivery.Sustained performance through lean leadership, robust learning and development planning, organisation talent reviews and communication planning.Builds partnerships within the Quality leadership team (QLT) to create and sustain a culture that demonstrates excellence in quality and continuous improvement.Creates an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management, and a learning organisation.Responsible for individual goal setting, ongoing performance reviews and development planning for direct reports and function.Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on resolving obstacles to maintain a highly effective and productive functional group.Responsible for ensuring compliance with legal, EHS and all policies and procedures which are applicable to the site.Role model the behaviours that creates a culture of respect and dignityTop of Form

Your profile

Degree Qualification. (Science/Quality/Technical or related), a master’s is desirable but not a requirement.A minimum of 8 years’ experience working in the pharmaceutical industry, preferably in a Biologics company.Proven people manager and leader capable of developing people and team with demonstrated management experience in a previous role.Track record of effective Quality Control leadership for internal production facilities with experience driving out inefficiencies and improving laboratory turnaround times.Knowledge of Analytical Method Development, Analytical Method Validation and Statistical Quality Control.Experience leading, training and/or implementing root cause analysis and effective investigation practices.Experience with working in a multinational organization. Experience working in a GMP/regulated environment.Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

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Current Contingent Workers apply HERE

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

02/18/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R334518