Senior Director, Site Quality Head

Job Description:

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-- 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

Qualification & Experience

• Required – bachelor’s degree in chemistry, Biology, Pharmacy
• Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy
• Key Requirements
• Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including:
• Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process,