Facility Operational Readiness Associate Director

MSD Malaysia; Dundalk; Hybrid; EUR 140,000 - 200,000; Full time

Benefits offered by this job

Hybrid work model

Flexible working arrangements

Job summary

MSD Malaysia is seeking a senior Facility Operational Readiness Associate Director for its Dundalk site to lead cross‑functional readiness activities across manufacturing, quality, engineering, and supply chain. The role partners with site leaders to align priorities, manage risks, and drive readiness from commissioning through to routine manufacturing in a fast-paced biotech environment.

The incumbent will oversee governance forums, manage complex project schedules, and prepare senior

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Business, Supply Chain or related discipline.
• Significant experience in pharmaceutical/biotech or vaccine manufacturing.
• Strong GMP, quality systems, validation and regulatory compliance knowledge.
• Experience leading cross-functional programmes in a regulated manufacturing environment.

Responsibilities

• Coordinate and drive readiness activities across multiple functions to support successful product launches and manufacturing.
• Facilitate governance forums, readiness reviews, action tracking and escalation processes.
• Maintain visibility of risks, milestones and issues; enable proactive resolution of blockers.
• Support transition from commissioning/qualification to normal manufacturing and continuous improvement.

Skills

Cross-Functional Program Management

GMP Knowledge

Stakeholder Management

Strategic Planning

Communication & Presentation

Problem Solving

Education

Bachelor's degree in Engineering/Life Sciences/Pharma

Tools

MS Project

Lean Six Sigma

PM Certification (PMP/PRINCE2)

Job description

About the Role and Site

Join a state-of-the-art vaccines manufacturing facility in Dundalk and play a pivotal role in preparing the site for successful product launch, process performance qualification, and commercial manufacturing operations. As the Facility Operational Readiness Associate Director (AD), reporting to the Site Operational Readiness Lead, you will act as a key partner to department leads, helping to coordinate and drive readiness activities across multiple functions. Working closely with Manufacturing, Quality, Engineering, Supply Chain, Digital, Facilities, and Technical teams, you will ensure critical operational priorities remain aligned, risks are proactively managed, and readiness plans are executed successfully. This is an excellent opportunity for a highly organised and influential professional who thrives in fast-paced environments, enjoys solving complex challenges, and can bring people together to achieve common goals.

• Support the delivery of operational readiness strategies and plans linked to successful manufacturing and product launch activities.
• Coordinate cross-functional readiness activities across multiple workstreams, ensuring alignment of priorities, timelines, and dependencies.
• Facilitate governance forums, readiness reviews, action tracking, and escalation processes to support effective decision‑making.
• Partner with functional leaders to ensure readiness across quality systems, training, supply chain, manufacturing systems, facilities, and operational processes.
• Maintain visibility of programme risks, issues, and key milestones, helping teams resolve challenges before they impact delivery.
• Support the transition from commissioning and qualification activities through to operational readiness and routine manufacturing.
• Drive operational rehearsal activities, scenario planning, and contingency preparedness.
• Build strong relationships across site functions to enable collaboration and alignment.
• Support executive communications and reporting, providing clear insights on progress, risks, and priorities.
• Identify opportunities to improve readiness frameworks, governance processes, and ways of working while capturing lessons learned for future initiatives.

What Skills You Will Need

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Business, Supply Chain, or a related discipline.
• Significant experience within the pharmaceutical, biotechnology, or vaccine manufacturing industry.
• Strong understanding of GMP manufacturing operations, quality systems, validation, regulatory compliance, and operational excellence principles.
• Experience supporting facility start‑up, operational readiness, technology transfer, process validation, PPQ, product launch, or commercial manufacturing activities.
• Proven track record of leading or coordinating complex cross‑functional programmes within a regulated manufacturing environment.
• Strong stakeholder management and influencing skills with the ability to build credibility across all levels of an organisation.
• Demonstrated ability to manage competing priorities, navigate ambiguity, and deliver results in a fast‑paced environment.
• Excellent communication, presentation, planning, and organisational skills.
• Experience preparing updates, recommendations, and risk assessments for senior leadership teams.

Preferred Experience

Experience supporting a new facility start‑up, expansion programme, or major manufacturing transformation. Experience within vaccine, sterile, biologics, or large molecule manufacturing operations. Project Management, Lean Six Sigma, PMP, PRINCE2, or equivalent certification.

Required Skills (Keywords)

• Business Decisions
• Cross-Functional Teamwork
• Decision Making
• Good Manufacturing Practices (GMP)
• Interpersonal Relationships
• Operational Excellence
• Product Launches
• Stakeholder Relationship Management
• Strategic PlanningStrategic Thinking
• Technical Problem-Solving
• Technology Transfer

Preferred Skills

• Business Decisions
• Cross-Functional Teamwork
• Decision Making
• Good Manufacturing Practices (GMP)
• Interpersonal Relationships
• Operational Excellence
• Product Launches
• Stakeholder Relationship Management
• Strategic Planning
• Strategic Thinking
• Technical Problem-Solving
• Technology Transfer
• Secondary Language(s)

Company Commitment

We 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 inclusive, 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.

Work Arrangements

• Flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Employee Status and Job Posting Details

• Employee Status: Regular
• Relocation:
• VISA Sponsorship:
• Travel Requirements:
• Flexible Work Arrangements:
• Hybrid Shift:
• Valid Driving License:
• Hazardous Material(s):
• Job Posting End Date: 10/14/2026 *A job posting is effective until 11:59:59PM 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.

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.