Job Description Summary
The Head of Quality will be managing and directing all Quality Assurance and Quality Control activities at Alcon Singapore Manufacturing (Aseptics, eyedrops) and ensure that Medical Devices and Pharmaceutical products are in compliance with local, European, USA and other internal regulations where applicable.
Job Description
- Management Representative, Responsible Manager and Release Authority responsibilities in accordance with the applicable Quality System Standards and regulations (see specific position description on the appointment letter).
- Delegate PRRC responsibilities in accordance with EU regulation (see specific position description on the delegate PRRC appointment letter).
- Ensure compliance with regulations (e.g. 21 CFR 210 /211 and Medical Device Regulation 2017/745) and established standards (ISO/EN ISO 13485:2016)
- Participate in the design, implementation, monitoring, and maintenance of an effective Quality Management System.
- Demonstrate strong and visible support for the Quality Management System, ensure its implementation throughout the organization and advocate continuous improvement.
- Maintenance of the local Quality Management System, including ensuring that only the current version of the Quality Manual is available for use.
- Ensure products comply with market authorization and GMP requirements and advocate continuous improvement during manufacturing, distribution, and shelf life, both for products manufactured at the site and for Third Party products managed by the Site or Functional Unit.
- Ensure management training on and awareness of quality and compliance requirements and systems.
- Ensure appropriate disciplinary actions are taken in case of willful or negligent GxP and Quality Management System violations up to and including termination of employment.
- Monitor effectiveness of Quality Management Systems, including performance of self-inspections, metrics monitoring and participation in management reviews.
- Ensure appropriate and timely escalation to management for quality related matters.
- Ensure all personnel are properly trained and qualified to execute their duties.
- Ensure appropriate interface with authorities for any GxP and Quality Management System related activity.
- Conduct management reviews of process performance and product quality and the Quality Management System.
- Participate in the development of the Alcon Quality Plans, and ensure its implementation, maintenance, and review.
- Responsible for all quality and compliance related decisions for the site, and for implementing the Site quality management programs.
- Manage department budget and establish headcount requirements based upon production plans and regulatory requirements.
- Accountable for compliance of the site to Alcon’s global ACM, BCM & business compliance processes.
- Ensure internal controls per CLC, AFCM, Alcon/Site/Finance SOPs, policies, and guidelines.
- Responsible for providing a work environment free from recognized hazards and ensure compliance with all applicable laws and regulations.
- Manage any projects / activities as and when assigned.
- Involve in people development plan: Leads people processes through recruitment, training, coaching and performance to meet all operational requirements; Ensure effective resource planning, participates in the recruitment, training, and assessment of Quality associates; Coach associates in the areas of technical and professional development.
Requirements
- Bachelor of Science, Engineering, or other Life Science.
- 10 years pharmaceutical / medical device (drug product) industry experience.
- 10 years industry experience covering Quality Assurance and Aseptic Processing.
