Senior Director, Site Quality

Role Overview

• Leads the Quality organization on site including Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations
• Ensure a current Quality Management System is in place and continuously improved
• Ensure products are manufactured, released and distributed in accordance to cGMP requirements and registered specifications
• Most senior professional and independent decision maker authority on product quality and potential market actions
• Assess and Mitigate Risks-
• Identify quality risks and define proactive mitigations, to ensure the products are safe and effective before they reach the market.
• Work with the business to assure compliant and reliable supply
• Design and Implement the Site Quality Program—Collaborate with the Site GM and Corporate Quality to create, implement, monitor and update the site quality program.
• Manage Quality Data--Oversee the delivery of necessary data to site managers and supervisors, Corporate Quality and other internal and external stakeholders, to support the achievement of Quality objectives and ensure compliance
• Direct Quality Control-
• Oversee the laboratory activity, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products for the site
• Promote a Sustainable Culture of Quality---Create, develop and maintain a culture of enhancing quality throughout the entire site operation.
• Create a space where people can speak openly and are encouraged to present new ideas to improve quality
• Maintain strong partnership with site leadership team
• Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met
• Provide effective Quality leadership during internal, customer and Health Authority inspections
• Ensure that Quality KPIs are meeting pre-defined targets
• Ensure CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically
• Plans, manages and monitors the annual Quality Operations budget and all its resources and employees.
• Ensure the performance and utilization of resources to provide maximum efficiency to the organization.

Requirements

• Required – bachelor’s degree in chemistry, Biology, Pharmacy
• Preferred
• Master or equivalent degree in Chemistry, Biology or Pharmacy
• Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience
• Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process
• High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions
• Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types
• Strong understanding and experience in Data Integrity and Compliance
• Experience preparing and/ or leading regulatory authority GMP
• Deep knowledge of Quality Systems
• Proven successful track record of leading organizational change to improve efficiency
• Experience leading, inspiring and coaching large teams
• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes
• Must have adequate knowledge of Quality best practices
• Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control
• Must have adequate practical knowledge of analytical techniques and microbiological principles
• Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer
• Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools
• Good knowledge of environmental, health and safety requirements for laboratories and quality operations.

Benefits

• Generous annual leave
• Reward plans
• Flexible working schedules (dependent on role)
• Access to tailored health support
• Meaningful ways to give back to the community