Quality Systems & Compliance Senior Manager

Quality Systems and Compliance Senior Manager

As Quality Systems & Compliance Senior Manager you will play a key role in supporting all sites 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 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 issuesvia directly supporting and as a leader for Quality Systems & Compliance team.

Organization Description

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover develop and manufacture biologics from concept to commercial manufacturing. 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 currently employ over 12000 people and provide services to more than 600 customers worldwide including all the top 20 biopharmaceutical companies.

As Quality Systems & Compliance Senior Manager you will 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 QMS Lead.

Essential Duties and 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 were 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.
• Will act as a role model for the Quality Assurance function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture

Your Profile

The ideal candidate for this position will have the following:

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:

Required:

• 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.

Behavioural 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.
  
  

Desirable:

• Business acumen/commercial awareness.
• Auditing Experience.

Other Requirements

• There may be a requirement for occasional travel to locations within Ireland and overseas to support business needs. Must be willing to travel when required.
  
  

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 - dont 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 or contact us via WuXi Biologics is an equal opportunities employer.