Job Description

Are you passionate about upholding the highest standards of quality and regulatory compliance? Our company is seeking a dedicated and experienced Quality System Lead to join our team at the Dundalk facility. In this key management position, you will play a crucial role in ensuring our Quality Systems and Compliance team objectives are met. If you thrive in a dynamic environment and are committed to excellence, we invite you to apply and be part of our mission to deliver innovative health solutions. 

 

Your Core Responsibilities 

Support the implementation of and maintenance of Global IT Quality Systems and ensure compliance with QMS requirements and procedures. 

Support the operation of the documentation management system that aligns with regulatory requirements. 

Lead delivery of new Quality System initiatives 

As required, ensure an effective change management system is in place to assess the impact of changes on products and processes. 

Coordinate QA related activities and participate in global forums as required 

Provide quality support, training, and guidance on company guidelines and regulatory requirements for Quality System/s 

Represent the site’s Quality System during GMP inspections and FDA PAI readiness activities 

Act as delegate for Site QA Lead as required 

 

Who You Are 

You are ready if you have: 

Bachelor's degree in Science, Quality, Engineering, or a related field. 

Minimum of 10 years of experience in Quality Assurance/Compliance, including at least 5 years in a people management role. 

Excellent knowledge of cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, and Training. 

Proven track record in people management within pharmaceutical or biotechnology organizations. 

Experience in the rollout and implementation of quality systems. 

Demonstrated audit/ inspection support experience 

Nice to have, but not essential: 

Previous experience in a start-up facility or an acquisition process would be highly advantageous. 

 

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

As a company, we are committed to 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.  

 

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.  

 

So, if you are ready to: 

 

Invent solutions to meet unmet healthcare needs, please apply today. 

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:

05/9/2025

*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:R344656