Facility Operational Readiness Associate Director

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. 

 

Bring energy, knowledge, and innovation to carry out the following: 

• 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:

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

Preferred Skills:

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Secondary Language(s) Job Description:

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.

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.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

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:

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.