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Senior Project Manager – Process Development

Recruitment by Aphex · Dublin

Senior 🇬🇧 English
cGMP GMP

Job description

About the role

The Senior Project Manager, Process Development leads new drug product introductions (NPI) and lifecycle management (LCM) projects within a matrix organisation. Reporting to the Senior Manager, Process Development, the role coordinates cross‑functional teams to deliver integrated plans, maintain governance, and ensure safe, compliant, on‑time execution.

Key responsibilities

  • Establish alignment on project goals, scope, deliverables and success criteria across teams and stakeholders.
  • Develop and maintain integrated project plans covering quality, schedule, cost, resources and performance tracking.
  • Lead governance forums and core team meetings, ensuring clear communication, decision‑making and accountability.
  • Drive cross‑functional execution of NPI and LCM initiatives for drug product (DP) and final drug product (FDP) projects.
  • Partner with site SMEs, functional managers and global functions to secure resources and resolve issues.
  • Own risk, issue and change control management, generating GMP change controls as required.
  • Ensure all activities comply with cGMP, EHS, quality system requirements and business guidelines.

Required profile

  • Strong project and program leadership experience in a regulated, matrix environment.
  • Proven ability to influence and lead multinational, cross‑functional teams without direct authority.
  • Excellent communication skills to keep stakeholders informed of risks, decisions and status.
  • Demonstrated capability to manage scope, schedule and budget throughout the project lifecycle.
  • Commitment to a culture of compliance, personal accountability and right‑first‑time execution.

Required skills

  • In‑depth knowledge of cGMP and GMP change control processes.
  • Proficiency in project planning, risk management and governance methodologies.

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Published 2 months ago

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Recruitment by Aphex

Dublin