Job Description

An amazing opportunity has arisen for a Change Control Topic Lead.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

Lead and maintain the change control business system (as Site Topic Lead for QMS Topic 3.4).Initiation, ownership and management of changes as required.  Changes may be related to processes (both commercialization and supply), cleaning, supply chain or other technical functions as required.Provide oversight, input, and guidance on change requests in terms of technical content, business process and the change control application.Liaise with the global business process owners and change control Community of Practice to resolve issues and strive for continuous improvement.Provide mentoring/hypercare as required, and complete administration activities on behalf of site users of change control systems.Attend community of practice meetings for change control, and champion global directives for improvements to business systems and processes.Owner and chair of the site Change Collaboration Meeting, and key attendee of Supplier Change Evaluation meetings.Attend Tier 3 to discuss endorsements for all Change Request with potential regulatory impact.Generate and monitor monthly change control metrics, and review and respond to Quality Council metrics.Provide guidance to change initiators/owners and advise on monitor and management of changes in change control applications.Attend Quality Council and complete annual review for change control as Site Topic Lead.Provide support as needed to pre-PAI, PAI and GMP inspections, both on-site, remote and paper based inspections.

What skills you will need:

In order to excel in this role, you will more than likely have:

3rd level qualification in a Science or Engineering discipline or a related field.5+ years experience in a related disciplineCommunication skills, oral & writtenProject ManagementDecision making and problem solvingLeadership principlesQuality Policies and ProcedurescGMP and Manufacturing policies & proceduresTeam work skills and ability to work across boundaries

As a company, we are committed to ‘Inventing for Life’ in all that we do. 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.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/18/2025

*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:R338303