Overview
WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU and Asia. The company currently employs over 12,000 employees worldwide, and are providing services to over 600+ clients globally, including 13 of the top 20 biopharmaceutical companies.
Job title: Quality Systems and Compliance Senior Manager
As Quality Systems & Compliance Senior Manager, you will play a key role in supporting all site’s functions to ensure the highest standards of professional excellence and quality assurance in the business, with responsibility for ensuring that a strong quality management system is in place, and adhering to all regulatory, cGMP and company requirements. Additionally, you will implement all necessary standards to consistently maintain a high level of quality and ensure the risk management program is inclusive of facility, utility, equipment, manufacturing process, and quality issues, directly supporting and leading the Quality Systems & Compliance team.
You will 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 QMS Lead.
Responsibilities
* Lead QA systems & compliance team providing quality monitoring and QA oversight to all site functions related to quality systems’ implementation and risk management program.
* Supervise direct reports on a day-to-day basis, provide training and communications, assignment, and prioritization of work.
* Manage performance, delivery of objectives and career development of direct reports.
* Provide QA review and approval of SOPs, where related to quality systems or centralized procedures in the site.
* Lead the Quality Risk Management program for WuXi Biologics Ireland.
* Leading, supporting and coordinating the Risk Register program.
* Manage, develop, and oversee the WuXi Biologics Ireland Site Master File, Regulatory updates implementation, Deviation, Change Control, CAPA and different quality systems including relevant trending as deemed necessary.
* Guiding different site functions where related to quality systems implementation and compliance.
* Point of contact with the Global Quality Standards & Operations and Global Quality Service Teams.
* Point of contact for global quality programs (e.g., harmonization programs and global vaults).
* Organise training relevant to the different quality systems (e.g., TrackWise trainings).
* Governing and reporting key quality metrics.
* Participate in Health Authority(ies), client(s), supplier(s), and internal audits as required.
* Manage, coordinate, and support the Quality Management Review (QMR) and escalation processes.
* Manage annual product quality review (APQR) program.
* Liaise with different site functions to ensure that all quality systems requirements are adequately addressed in a timely manner as defined in SOPs.
* Liaise with key stakeholders in supporting daily operations.
* Ensure clear communication on issues and timely escalation as applicable.
* Identify and drive a culture of continuous improvement in the site.
* Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
* Collaborate internally and also across the WuXi network to achieve quality goals.
* Lead and/or represent QA on multidisciplinary teams, as required.
* Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
* Will be flexible to take on additional tasks and responsibilities at the discretion of the QMS Lead.
Your Profile
Education:
* Preferable that the individual has qualification Degree in Biopharmaceutical/ Pharmaceutical Science or other related science discipline.
Experience/Knowledge:
* More than 8 years’ experience in the biotechnology and/or pharmaceutical industries within a Quality role, preferably in quality systems, risk management, auditing, or QA operations within the biopharmaceutical/ pharmaceutical industry.
* Experience of leading teams is essential (With at least 3 direct reports).
* Strong Quality Risk Management execution experience.
* Experience in performing internal audits would be an advantage.
* Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
* Demonstrated knowledge of ICH, EU GMP and FDA GMP regulations.
* Demonstrated knowledge of and proven experience in implementing investigational tools, root cause analysis and driving closure of investigations.
Technical Competencies:
* Ideally, experienced in establishing a Quality Management Systems in biopharma or similar pharma/science industry.
* Strong technical aptitude (i.e., able to read & comprehend technical documentation & execute procedures).
* Strong knowledge of cGxP and GLP requirements, and regulations.
* Knowledge of trouble shooting and problem-solving skills, e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc.
* Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
* Demonstrated knowledge of quality systems’ trending reports/ studies.
Behavioral Competencies
* Proven decision-making capabilities.
* Demonstrated collaboration, negotiation, conflict resolution skills, and inclusive approach with a teamwork mindset.
* Analytical, problem solving & root-cause analysis skills.
* Able to challenge the status quo with a continuous improvement mindset.
* Excellent interpersonal, verbal, and written communication skills.
* Self-starter and self-motivated; organized with good attention to details.
* 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.
* Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations.
Additional
Would you like to know more before you apply? Please visit us at or contact us via WuXi Biologics is an equal opportunities employer.
Skills
* QMS
* Quality Oversight
* Leadership
* Stakeholder Management
Benefits
* Bonus
* Parking
* Pension
* VHI
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