Associate Director managing Gender, Equality, Diversity & Inclusion initiatives for International Rescue Committee. Overseeing strategic planning and project delivery across departments.
About the role
- Senior Director overseeing site quality for pharmaceutical manufacturing at Teva in Goa, India. Lead quality oversight, ensure compliance, and improve site quality culture.
Responsibilities
- Lead 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
- 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.
Requirements
- bachelor’s degree in chemistry, Biology, 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
CM
Director of Knowledge Management at SKEMA Business School transforming knowledge into operational efficiency. Leading initiatives across multi - campus environments with focus on collaboration and performance.
Director, Clinical Development leading medical guidance for rare liver diseases at Ipsen. Collaborating across teams to design and implement clinical trial protocols with regulatory compliance.
Director of Customer & Channel Management focusing on customer strategies for Pfizer's oncology products. Leading national accounts initiatives and team collaboration with cross - functional partners.
Managing Director overseeing transportation business strategies for Enghouse, a tech - driven mobility company. Responsible for P&L, scaling operations, and fostering partnerships.
Divisional leader at Enghouse, managing B2B enterprise software businesses in transportation sector. Responsible for strategy, growth, and operational execution in multimodal mobility platforms.
Managing Director in transportation at Enghouse, leading strategies for B2B enterprise software in the mobility sector. Overseeing operations and partnerships in complex environments.
Director Product Integrity overseeing quality, compliance, and safety initiatives across retail products. Collaborating with cross - functional teams to drive customer trust and brand protection.
Director of Engaged Learning at Emory University coordinating university - community engagement and developing community - based learning initiatives. Leading workshops and managing the engaged learning budget with collaborative faculty support.
Senior Director responsible for balance sheet risk management at DCU credit union. Overseeing risk management practices and aligning strategy with business objectives.