QC Operations Lead

QC Operations Lead (Associate Director)

The QC Operations Lead (Associate Director) 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.

Department Description

As QC Operations Lead youll be joining an organization where people of all backgrounds and experiences are respected and where we work together focused on changing this role you will report to the Head of Quality Control.

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.
• The role will require extensive liaison with counterparts and business leaders in WuXi Biologics corporate to include the highest level of professional representation of the local site QC organisation.
• From a QC functional capacity 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.
• Communicate collaborate 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 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

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.

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.

Experience/Knowledge:

• 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.

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.
• Strong leadership competencies with demonstrated management skills.

Onerous requirements

• Up to 15% domestic and international travel.

As we extend our global reach we need colleagues interested in change in challenge and in building a new future together. Apply now! WuXi Biologics is an equal opportunities employer.

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