Senior Director, Site Quality Head, Goa

Role Summary

Senior Director, Site Quality Head, Goa — Lead on-site Quality organization at the Goa Teva site, overseeing Quality Control, Microbiology, Quality Compliance, Quality Systems and Quality Assurance Operations. Drive a mature culture of quality, regulatory compliance, and continuous improvement aligned with cGMP requirements and global standards.

Responsibilities

• 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‚ÄîIdentify 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‚ÄîCollaborate 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, Ensures 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.

Qualifications

• Required ‚Äì bachelor‚Äôs degree in chemistry, Biology, Pharmacy
• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy

Skills

• 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
• Understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines, and CMC content of regulatory submissions
• Knowledge of chemical/pharmaceutical production operations/lifecycle, production equipment/validation, and relevant technologies
• Strong Data Integrity and Compliance
• Experience preparing and/or leading regulatory authority GMP
• Deep knowledge of Quality Systems
• Proven track record of leading organizational change and coaching large teams
• Experience developing and implementing improved business processes
• Knowledge of Quality best practices and practical knowledge of pharmaceutical manufacturing and/or control
• Practical knowledge of analytical techniques and microbiological principles
• Practical knowledge of cross-functional operations (e.g., Supply Chain, Engineering), product and tech transfer
• Practical knowledge on lean manufacturing/QC and OPEX tools
• Knowledge of environmental, health and safety requirements for laboratories and quality operations