Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Senior Director of Site Quality at Teva Pharmaceuticals overseeing quality operations and compliance in Goa, India. Leading initiatives and ensuring adherence to cGMP requirements.
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
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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