QC Operations Lead

Life Science Recruitment; Dundalk; On-site; EUR 120,000 - 150,000; Full time

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.

Skills

Management

LIMS

Empower

ECM

Master Control

Trackwise

Maximo

Microsoft Word

Excel

PowerPoint

Visio

Project

Education

Ph.D. in related field

MSc/Masters in related field

University degree in related science/quality

Tools

LIMS

Empower

ECM

Master Control

Trackwise

Maximo

Job description

QC Operations Lead (Associate Director)

Our client are currently recruiting for a QC Operations Lead (Associate Director) to join their team on a permanent basis. As QC Operations Lead you will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility for the management of QC instruments/equipment, computer systems, sample management, project support, and general QC-compliance functions. Working closely with senior leaders in all areas of the business, this position will play an integral role in the development of the local QC strategy/business planning, aligned closely with the global QC function.

Responsibilities:

• Key member of the QC leadership team. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
• Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives.
• Support the design, construction, and commissioning of the new facility for the production of drug substance.
• Develop/build a world-class Biologics QC Operations team, including planning, recruiting/hiring, coaching/mentoring, and training for approximately 15-20 total headcount
• Management of QC instruments, equipment, and systems, including equipment installation, qualification, and computer systems validation
• Issue and control calibration and PM logbooks and instrument/equipment labels (instrument identification and calibration)
• Supervise implementation of QC-specific computer systems, including LIMS, Empower, ECM, ELN
• Serve as QC-representative for other GMP computer programs, including Master Control (and/or other document storage and training software), Trackwise, Maximo, etc.
• Supervise QC Project Lead Team (PLs), who serve as the liaison between QC, the client, and other stakeholders tracking QC activities to ensure on-time and high-quality support.
• Monitor QC compliance, including tracking QC-deviations and routine assessment of local and global regulations
• Lead team to author technical documents, including relevant SOPs, testing protocols and reports (i.e. in-process testing, release, and stability), product specifications, product expiries
• Serve as a technical lead in applicable deviations, change controls, and CAPAs
• Represent Operations team in regulatory inspections and client and internal audits
• Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence.

Requirements:

• 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