Job Description
Are you passionate about upholding the highest standards of quality and regulatory compliance? Our company is seeking a dedicated and experienced
QMS and Projects Lead
to join our Quality team at the Dundalk facility. In this key position, you will play a crucial role in ensuring our Quality 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
* Lead the integration, deployment and maintenance of our Global Quality Manual
* Manage the operation of the documentation management systems to comply with the Quality Manual
* Quality Projects Define project scope, objectives, deliverables, success criteria, and acceptance standards for Quality initiatives in alignment with associated stakeholders.
* Develop and maintain comprehensive project plans (timelines, milestones, dependencies, resource allocations)
* Facilitate project meetings (kick-offs, launches, milestone reviews, steering committees) and maintain meeting minutes, action logs, and decision records.
* Manage project changes through the required change-control process and ensure any updates to QMS documentation and training materials reflect approved change
* Provide coaching and guidance to project team members on project management best practices, tools, and templates as they relate to Quality System initiatives.
* Participate in global Quality 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
* 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.
* Experience in leading Quality related Projects previously is preferred
* 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)
Required Skills
Preferred Skills
Job Posting End Date
09/20/2025
* A job posting is effective until PM 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