As QC Equipment and Systems Senior Manager, you will be responsible for leading and managing all project and sustaining delivery functions in the QC Analytical workstream for equipment and systems and will provide vision, leadership and direction for the QC Equipment and Systems team.
Organisation Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Department Description
As QC Equipment and Systems Senior Manager, you’ll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
In this role you’ll be reporting to the QC Operations Lead (Associate Director).
Your Responsibilities
- Creates a diverse and inclusive culture that excels in safety, quality and delivers on the strategic vision for the QC Department.
- Ensure following the requirements of EudraLex cGMP guidelines.
- Leads the QC Equipment and Systems Team for the installation, qualification, operation, and retirement of QC Systems and equipment for the QC Laboratories.
- Leads continuous improvement of QC Operations, through their QC Systems knowledge and areas of expertise.
- Manage the purchasing, installation, qualification, building, maintenance, and integration of QC Systems, as required, including divisional systems, instrumentation, and associated equipment, in compliance with up-to-date data integrity, regulatory, and industry standards.
- Author, review and approve technical documents, standard operating procedures, deviations, investigations, change management related to QC Equipment and Systems.
- Act as Project management to meet established QC Systems delivery timelines.
- Work cross-functionally with our company's sites and stakeholders to successfully implement Technology Enabled Labs capability within the QC department.
- Define and lead the change management process and mechanisms required to maintain QC Equipment and Systems in a validated state throughout their lifecycle.
- Troubleshoot equipment, systems, instrumentation and their associated software as subject matter expert (SME) in a timely manner
- Lead, coach and mentor the QC Equipment team. Build diverse talent with the capabilities necessary to succeed in commercial drug substance manufacture.
- Develop team members through supporting their continued personal and professional career growth.
- Assisting in and facilitating investigations (leading where required), ensuring effective Root Cause Analysis and CAPAs.
- Represent the QC department as a QC Systems SME for internal audits/regulatory inspections and support permanent inspection readiness.
- Escalate potential cGMP or compliance issues effectively in a timely manner for appropriate resolution to ensure product quality.
- Report and drive own metrics that appropriately and accurately measure QC performance, take action to mitigate risk as required.
- Manage and facilitate Equipment tier meetings and support various site functional and cross functional tier structures.
- Actively participate in Site/Quality committees and works with other site functional groups to help set direction for GMP and continuous improvement initiatives.
- Be customer facing and support client meetings, scoping project plans and customer needs.
- Responsible for managing risks, completing impact assessments and developing mitigation strategies and escalation as necessary.
- Collaboration with departments across the business including Manufacturing, QA, Supply Chain, Procurement, Engineering and EHS to ensure the project needs are met.
- Manage the release of each instrument/equipment in alignment with NPI (New Product Introduction) and the Production schedule and deliver through the planning process with relevant stakeholders such as CAPEx Project Engineers, PEV, QA, QC System Owners and Engineering.
- Report out to SLT and Client when required regarding workstream progress using weekly slides, weekly schedule progress tracker, System Release Tracker.
- Ensure documentation deliverables are met as per the relevant categorisation of each instrument and associated SOPs.
- Identifying and monitoring key milestones and addressing issues that may impact the critical path of the schedule.
- Manage QC Equipment and System schedules as required e.g. Equipment PM/PV, periodic reviews, calibrations to ensure there is no impact to the QC Laboratories.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents as required.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the QC management team.
- Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values.
Person Specification
Technical Competencies
- Strong computer skills MS Office (WORD, EXCEL, PowerPoint).
- Excellent planning and organizational skills, prioritizing abilities and work efficiently.
- Demonstrated ability to manage multiple priorities against ambitious timelines.
- Strong stakeholder management skills and proven experience dealing with site groups
- Skilled in planning ahead to ensure any problems are resolved promptly and accurately.
- Excellent communication and interpersonal skills.
- Strong problem-solving skills and ability to work cross-functionally as critical member of site team.
Experience
- Minimum of 5 years’ experience working in a fast-paced environment.
- Experience in a GMP facility, in a lead or project management role is desirable.
- Experience with facility start-up projects (brown field or green field) is desirable.
- Experience in the management of complex cross functional projects.
- Experience in people leadership and developing others.
Knowledge
- Knowledge / experience in the operation of GMP Pharmaceutical Sites would be an advantage.
Qualifications
- Bachelors degree or higher qualification in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline.
- Masters degree would be an advantage
Behavioural Competencies
- Collaborative and inclusive approach to work and colleagues.
- Excellent problem solving and troubleshooting skills.
- Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
- Engage cross functionally in conjunction with a site-based team.
- Autonomous and a self-starter who will use their initiative to drive actions forward.
- Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.
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!
If you can thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.
Apply now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/
WuXi Biologics is an equal opportunities employer.
