More jobs:
Site Director - Biologics CDMO
Job in
Donaghadee, County Down, BT21, Northern Ireland, UK
Listed on 2026-09-14
Listing for:
Integrated Talent Partnership
Full Time
position Listed on 2026-09-14
Job specializations:
-
Manufacturing / Production
Regulatory Compliance Specialist
Job Description & How to Apply Below
The Role As Site Director, you will hold overall accountability for the performance, compliance, and culture of the site. You will lead a multidisciplinary team spanning manufacturing, quality, engineering, supply chain, and technical operations, ensuring the facility consistently meets GMP standards, client commitments, and business objectives.
Key Responsibilities Provide overall leadership and P&L accountability for the site, ensuring delivery against safety, quality, delivery, and cost targets Act as the site's Responsible Person/Qualified Person liaison, maintaining full compliance with MHRA, EMA, and FDA GMP requirements Lead, coach, and develop the senior site leadership team across Manufacturing, Quality, Engineering, and Supply Chain functions Own the site's health & safety culture, ensuring robust EHS systems and continuous improvement Drive operational excellence initiatives (Lean/Six Sigma) to improve right-first-time rates, capacity utilisation, and cost efficiency Serve as a key point of contact for major clients, supporting business development, technology transfer, and new project onboarding Oversee capital investment planning, site expansion projects, and long-term facility strategy Ensure inspection readiness and lead engagement with regulatory bodies during audits and inspections Represent the site within the wider corporate leadership structure, contributing to group-level strategy About You Significant senior leadership experience within biologics manufacturing, ideally within a CDMO, biopharmaceutical, or biotech manufacturing environment Proven track record of managing large, multidisciplinary teams and full site P&L responsibility Strong working knowledge of biologics manufacturing processes (upstream/downstream, fill-finish, or drug substance/drug product) and associated GMP regulatory frameworks Demonstrated success leading regulatory inspections (MHRA, FDA, EMA) with strong outcomes Commercially astute, with experience supporting client relationships and business growth Excellent leadership, communication, and change management skills Degree in a relevant scientific, engineering, or technical discipline;
advanced degree or professional qualifications advantageous
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×