Sr. Spclst , Technical Product Management

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.