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.

• 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 tobiologics and/or pharmaceuticals