QC Operations Director — Biologics (GMP)

Life Science Recruitment

Dundalk

On-site

EUR 120,000 - 150,000

Full time

10 days ago

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Life Science Recruitment is seeking a QC Operations Lead (Associate Director) in Ireland to drive QC strategy, manage instruments and systems, and lead a 15–20 headcount Biologics QC team. The role partners with senior leaders to ensure GMP compliance and regulatory readiness across the site.

The successful candidate will oversee calibration, validation, and computer systems (LIMS/EMPOWER/ECM/Trackwise/Maximo), and will lead cross-functional collaboration to deliver high-quality drug substance

Qualifications

University degree in related science/quality discipline required.
Ph.D. with 5-8 years of experience, or Masters with 7-10 years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field, desired
More than 15 years’ experience in Quality Control/GMP environment with a well-rounded exposure to all areas of this field, and specifically QC Operations
Experience with LIMS, Empower, ECM, Master Control, Trackwise, Maximo
Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project
Management/supervision of personnel with particular attention to schedules and shifting priorities
Previous experience with regulatory inspections and internal/customer audits is strongly preferred
Previous experience working in a CMO is a plus
Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals

Responsibilities

Key member of the QC leadership team and drive strategy and business planning.
Collaborate with senior leaders to achieve targets and objectives.
Support design, construction, and commissioning of the new facility.
Develop/build a world-class Biologics QC Operations team, including planning, hiring, coaching, and training for 15–20 headcount.
Manage QC instruments, equipment, and systems, including installation, qualification, and computer systems validation.
Supervise QC Project Lead Team coordinating QC activities with clients and stakeholders.
Monitor QC compliance and regulatory deviations.
Lead authorship of SOPs, testing protocols, reports.
Represent Operations in regulatory inspections and audits.
Introduce new technologies for continuous process improvements.