Job Description
Red Oak North in Dublin is our commercial Head Office for our Animal Health and Human Health businesses in addition to several global and national support services including Clinical Research, Medical Affairs, Regulatory Affairs, Sales, Policy Communications and Marketing.
We have a great opportunity for aSenior Technical Product Manager. Youll have the opportunity to work on multiple products at various stages of development and maturity, ensuring each one delivers high impact and aligns with our strategic goals.
What you will do:
Bring energy, knowledge, innovation, and leadership to carry out the following:
Test Compliance Strategy:
- Develop, deliver, and maintain a comprehensive Test Strategy for new and existing products that aligns with SDLC requirements, product roadmaps, and regulatory standards.
- Execute risk assessments to evaluate the compliance impact of new technologies or significant architectural changes.
- Communicate and champion changes to SDLC policies and procedures, ensuring site-wide adoption and understanding.
Audit Regulatory Management:
- Represent all compliance-related testing activities to internal and external auditors and regulatory agencies.
- Lead the development of audit responses and collaborate with local quality organizations to formulate effective strategies.
- Identify, assess, and drive the remediation of IT/OT compliance risks.
Quality Stakeholder Collaboration:
- Support local teams by providing expert guidance on quality and compliance challenges, ensuring adherence to SOPs and policies.
- Partner with stakeholders across Manufacturing, Quality, and Supply Chain to navigate conflicting priorities and balance tactical and strategic needs.
- Engage as an active member of the compliance group, sharing knowledge and best practices to enhance execution and conformance within the Digital organization.
Reporting Process Improvement:
- Report on challenges in execution or adherence to procedural trends identified through non-conformance.
- Track and report the status of local/site-based deviations, CAPAs, and other quality records as key indicators of control and conformance.
In order to excel in this role, you will more than likely have:
- Bachelor’s Degree in Computer Science, Engineering, Regulatory Compliance, Business Strategy, IT Architecture or a related field.
- A minimum of 5 years of experience supporting compliance activities in a regulated environment Pharma (Manufacturing, Supply Chain, or Quality)
- Proficient and demonstrated knowledge of regulatory requirements for computerized systems, including21 CFR Part 11 andEMEA Annex 11.
- Proven experience managing interactions with internal and external auditors/agencies.
- Working knowledge and practical application ofISA S95 andS88 standards in a GxP environment.
- Experience in validating/qualifying modern technology platforms, including Cloud (SaaS), advanced analytics, and data integration architectures.
- Strong understanding of end-to-end manufacturing business processes (Manufacturing, Quality, Supply Chain).
- Exceptional written and verbal communication skills, with the ability to articulate complex concepts simply and effectively to diverse audiences, including executive management.
- Strategic thinker with a results-oriented mindset, capable of developing and successfully implementing plans with a degree of ambiguity.
Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
Required Skills:
Annex 11, Audit Management, CFR 211, CFR 21 Part 11, EU Annex 11, Management System Development, Product Management, Regulatory Management, Software Development Life Cycle (SDLC), Software Validation, Stakeholder Relationship Management, Strategic Planning
Preferred Skills:
Current Employees applyHERE
Current Contingent Workers applyHERE
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:
08/10/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.
Requisition ID: R407933
