Director Quality and Regulatory Affairs
- Establishes quality and regulatory strategic goals by gathering quality, business, financial, service, and operations information; identifying and evaluating trends and options; choosing a course of action; defining objectives; evaluating outcomes.
- Provide guidance on development of procedures that maximize quality and regulatory standards; establishing and directing manufacturing sites on manufacturing quality and regulatory testing (incoming, in process and final release), including laboratory facilities for quality and regulatory testing of raw materials, finished goods, and goods in process.
- Develops strategies and implement programs to assure regulatory compliance and standards of quality and regulatory. Provides leadership in responding to FDA and other regulatory agencies in trends and GMP requirements. Manages GMP compliance audit programs. Executes control over all or some of the following programs/systems: change control, documentation control, product complaint investigation and analysis. Maintains quality and regulatory service by enforcing quality and regulatory and customer service standards; analyzing and resolving quality and regulatory and customer service problems (customer complaints, customer audits, customer surveys and/or quality and regulatory agreements, etc.); identifying product quality and regulatory trends; recommending corrective actions, (product quality and regulatory and/or quality and regulatory system improvements; conducting audits and follow up.
- Provide leadership and guidance on design for quality and regulatory to new product development staff. Serve as QA Sponsor - review /approval of project prior to release to next stage of design/development/launch. Activities typically include reviewing designs/plans of proposed new products;
- Reviews technical problems and procedures of departments by recommending solutions to problems or changes in procedures.
- Maintains professional and technical knowledge by attending educational workshops' reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; and participating in professional societies.
- Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
- Initiate and support workshops / events to continues improve standard work and performance.
- Oversight over company policy and system for notifiable events (vigilance system, MDR ) globally.
Global Quality and Regulatory
- Master degree in a Life Sciences discipline.
- Knowledge of ISO9001, ISO13485, 21 CFR 820 and ASIEN regulatory requirements.
- Minimum 7 years' experience in Quality Management systems.
- Significant experience in data analytics and problem solving.
- Ability to collaborate and communicate globally and cross-functionally.
- Ability to work effectively in a global, matrix organization.
- Demonstrated leadership skills.
- Must be prepared to be on call 24/7 due to emergencies, critical quality issues and regulatory issues.
- Willing to travel globally, including outside normal working hours. ( approx. 30%).
- To work safely and to comply with the company's health, safety and environmental (HSE) policies and procedures.
Our client is a global leader in medical filtration, separation and purification with its global headquarter based in Switzerland.
Great opportunity to join a matrix organisation with a multinational team to manage across the world.