A biotechnology company that focuses on researching and developing treatments using monoclonal antibodies, is seeking a Director of Quality System Compliance to join their team in China. This is a rare and excellent opportunity to join a leading company during a period of rapid development and growth. This position is highly influential and critical to achieving compliance improvement and as a result contributing to the organization's strategic goals for continued growth and commercial success.
This Director Quality System Complaince role is responsible for providing expert guidance and direction on all compliance aspects regarding quality system operation in the GMP and ICH compliant Company for new and existing products. This position will act as the Subject Matter Expert (SME) within the organization with the main objective of improving the overall compliance culture throughout the company facilities and sites. This position will be responsible for advising managers and other colleagues on compliance issues and will lead compliance projects when necessary.
Overview of Responsibilities:
- Identifying the root cause of compliance issues through internal / external audits and regulatory inspections, deviations and OOS investigations, participation in batch review and change control dialogue.
- Serving the quality system SME, responsible for influencing management team on all compliance issues and for developing best practices and action plans according to the GMP regulatory requirements and company quality standards.
- Responsible for advising management on internal, external audits and regulatory inspections, with continued business growth.
- Play an integral role in a cross functional team focused on new product development.
- Responsible for leading and managing Company quality system improvement initiative across all departments and functions to ensure that quality initiatives and quality plans are executed and maintained in full compliance with CGMP requirements. This includes addressing issues from quality management oversight and helping the site management team to execute effectively the quality enhancement activities.
- Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.
- Attend preparation and execution of internal, external and regulatory audits on the site.
- Ensure that company executive leadership team is well kept informed of all critical and major quality issues which may have an adverse effect on the product quality.
- Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including management of quality and product alerts.
- Contribute significantly to the development of best practice within the scope of GMP compliance and regulatory requirements; facilitate interaction and exchange of best practices with other departments and functional areas
Education and Experience:
- Advanced degree (MS or PhD) within pharmacy, biology or engineering and with at least 10 years' managerial experience in a production and/or quality function in the biotechnology / pharmaceutical industry.
- Expert in quality system implementation & improvement, which include but are not limited to Product Release & Production Batch Record, SOP, Training, External & Internal Audit, Regulatory Inspection, Change Control, Data Integrity, Customer Complaint Management, Qualification & Validation, Technology Transfer (Manufacturing Process & Analytical Method), Deviation and OOS Investigation, Quality Risk Management, External Supplier/Vendor Quality System, Quality Agreement, Quality Metrics, and CAPA Management for Non-conformance.
- Demonstrated leadership & experience in staff skill development, performance appraisal and department budget management.
- Experience in transverse management without direct hierarchical authority or supervision.
- Demonstrated ability to achieve results and manage others to achieve corporate, site and functional objective
- Ability to integrate the constraints of each function and identify good solutions while within compliance of regulation
- Team performance complemented by development of skills and performance of individual team members
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mandy Fang on +65 6499 7144 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Reg. No. R1215238 / EA Licence: 13C6865