Senior Manager of QC Operations
The Senior Manager of QC Operations 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.
Department Description
As QC Operations Team Lead, you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you will report to the QC Operations Associate Director
Essential Duties and Responsibilities
- Key member of the QC leadership team for WuXi Biologics Ireland. 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.
- Develop/build a world-class Biologics QC Operations team, including planning, recruiting/hiring, coaching/mentoring, and training.
- Management of sample and stability management for other DS and DP products.
- 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, etc.
- 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 .
- Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations
- Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
- Enhance collaborations by sharing knowledge and experiences across WuXi Biologics global sites.
- Thorough understanding of current Good Manufacturing Practices
- Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Associate Director.
- Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values and local site shared commitments/behaviours
Person Specification
Technical Competencies
- Ideally, experienced in establishing a QC function and building a team in a ‘greenfield’ context of similar size and scale
- QC Sample management, including: sample log-in and disposition (internal and external), routine inventory checks, respond to temperature excursion alarms.
- Maintenance/calibration schedules, performing maintenance/calibration and requalification of instruments (if applicable), coordinating the repair and instrument/equipment calibration.
Knowledge/Experience:
- More than 5 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, 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.
Qualifications:
- University degree in related science/quality discipline required.
- Ph.D. with 5 years of experience, or Masters with 5 years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology is desired
Behavioural Competencies
- Excellent interpersonal, verbal, and written communication skills.
- Able to think critically and demonstrate troubleshooting and problem solving skills.
- Self-starter and self-motivated; organized with good attention to detail.
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
- Results oriented, with the ability to manage multiple priorities in a short period of time.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential! Apply now!
WuXi Biologics is an equal opportunities employer.
