Job Overview
Senior Technical Product Manager at Red Oak North, Dublin, responsible for ensuring compliance and quality across multiple products in the Animal & Human Health businesses.
Responsibilities
- Develop, deliver, and maintain comprehensive Test & Compliance Strategies aligned with SDLC, product roadmaps, and regulatory standards.
- Execute risk assessments to evaluate compliance impact of new technologies or significant architectural changes.
- Communicate and champion changes to SDLC policies and procedures, ensuring site-wide adoption.
- Represent compliance‑related testing activities to internal and external auditors and regulatory agencies.
- Lead development of audit responses and collaborate with local quality organizations.
- Identify, assess, and drive remediation of IT/OT compliance risks.
- Provide expert guidance on quality and compliance challenges to local teams, ensuring adherence to SOPs and policies.
- Partner with stakeholders across Manufacturing, Quality, and Supply Chain to balance tactical and strategic needs.
- Report on challenges and trends in execution or adherence to procedural standards.
- Track and report status of local/site‑based deviations, CAPAs, and other quality records.
Qualifications
- Bachelor’s Degree in Computer Science, Engineering, Regulatory Compliance, Business Strategy, IT Architecture, or related field.
- Minimum 5 years of experience supporting compliance activities in a regulated environment (Pharma manufacturing, supply chain, or quality).
- Proficient in regulatory requirements for computerized systems, including 21 CFR Part 11 and EMEA Annex 11.
- Proven experience managing interactions with internal and external auditors/agencies.
- Working knowledge of ISA S95 and S88 standards in a GxP environment.
- Experience 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, capable of articulating complex concepts to diverse audiences including executive management.
- Strategic thinker with a results‑oriented mindset, capable of developing and implementing plans amid ambiguity.
Sr. Spclst , Technical Product Management in Baildon employer: MSD Malaysia
MSD Malaysia is an exceptional employer that values innovation and collaboration, offering a dynamic work culture where employees can thrive. With a strong commitment to professional development, the company provides ample opportunities for growth and engagement in meaningful healthcare initiatives across Scotland and Northern Ireland. Employees benefit from a supportive environment that encourages scientific excellence and fosters lasting relationships with key opinion leaders in the medical field.
