Job Description

We are seeking a Change Control Lead to join our innovative Commercialisation Team at our Ballydine Site. In this exciting position, you will play a crucial role in overseeing our change control system comply with industry standards and driving operational excellence.

Key Responsibilities:

• Lead and Inspire: Manage a dedicated team within the Commercialisation Team, guiding them in overseeing the change control system and facilitating the seamless progression of changes through the Integrated Process Improvement (IPI) system.
• Ensure Compliance: Uphold IPI Change Control requirements while consistently meeting site quality metrics for all change control activities, ensuring our operations are top-notch.
• Drive Efficiency: Identify and implement innovative efficiencies and improvements within the Change Control System team’s operations, enhancing productivity and effectiveness.
• Consult and Educate: Provide expert consultancy on change control activities to technical groups, focusing on continuous upskilling for Change Initiators and Change Owners to foster a culture of learning and growth.
• Develop Talent: Oversee the training and development of team members within the Change Control team, ensuring they have the skills and knowledge to excel.
• Monitor Performance: Track and analyse department monthly change control metrics, responding proactively to metrics and making necessary adjustments to optimize performance.
• Support Inspections: Facilitate support for Pre-Approval Inspections (PAI) and Good Manufacturing Practice (GMP) inspections, providing assistance for on-site, remote, and paper-based inspections.
• Adhere to Standards: Ensure strict adherence to global business processes and the Change Control system, maintaining our commitment to excellence.
• Empower Change Initiators: Guarantee that all Change Initiators and Change Owners complete the required training before requesting system access, promoting accountability and competence.
• Resource Management: Prioritize and allocate resources effectively for major initiatives and related changes, ensuring timely and effective implementation while minimizing unintended consequences.
• Collaborate for Success: Work closely with Change Initiators and Change Owners to support change objectives and enhance execution conditions, fostering a collaborative environment.
• Promote Community Engagement: Encourage participation in the Community of Practice to advance Change Control across the organization, promoting shared competence and collective growth.

What skills you will need: 

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

• A Higher Science Degree (BSc, MSc, PhD) with industry experience  
• Proven ability to manage teams collaboratively across various departments
• Strong communication skills, both written and verbal, with a focus on clarity and honesty.
• Leadership, communication, decision making and problem solving skills with a proven track record for effectively collaborating and working well within a team..
• High personal integrity, credibility and energy.
• Ability to manage multiple priorities and knowing when to escalate for resolution.
• Flexible and self-motivated, with proven ability working cross functionally delivering technical solutions to issues.

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/18/2025

*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.