Holds overall QA QC GMP Responsibility for Site in the Emerging Markets. Provide strong leadership and oversight to ensure responsibilities regarding QA, QC and all other QMS activities. The candidate is accountable for assuring the supply of high quality, GMP compliant drug products to Sun Pharma customers and markets. Responsible for leading, directing, identifying and setting quality goals, objectives, and ensuring perfect execution in alignment with Global Quality Goals. Candidate will maintain substantial compliance at all sites, including harmonization and implementation of Quality Systems procedures in alignment with Global Policies Standards. Acts as a champion for building a Culture of Quality across the organization. Accountable to assure all sites are ready for all Regulatory and Customer inspections at all times. Responsibilities Assigned: Ensure all Finished products and APIs intended for use in the market are safe and effective as per cGMP requirements, regulatory commitments, Sun policies SOPs. Track, trend, maintain and report all Quality and business metrics to monitor and action all QA QC compliance activities. Prevent Quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company. Non-compliance issues are to be addressed through corrective and preventive actions (CAPA). Ensure rationalization and management of Quality processes, operations and systems. Perform gap analysis to plan actions for continuous improvements. Resource planning and monitoring for head count projections, revenue, budget, capital budget and manage organizational development. Responsible for global lean design and execution of continuous Quality Compliance improvement initiatives, standardizations and efficiency gains to enhance compliance, drive efficiencies and reduce cost of poor quality. Coach and develop direct and indirect reports, as appropriate, through ongoing, examples-based performance feedback, annual performance reviews and the provision of training and development opportunities. Perform all work in support of our Corporate Values of Humility, Passion, Integrity, Innovation, Quality, Reliability, Consistency and Trust and in accordance with established regulatory and compliance and safety requirements. Lead Global Projects as part of collaboration with GQLT. Act as key resource and provide guidance with regards to global regulations to Sun Pharma sites and affiliates to ensure overall harmonized approach to quality and compliance. Be a solution-oriented leader and role model SUN behaviors. Maintain a network of subject matter experts in critical GMP Operations. Support the development of global strategy to respond to system level audit observations, inspection findings and implement corrective actions, globally. Responsible for tracking and trending of monthly global QA reports, Global KPIs, QPIs and global quality complaints and assures all compliance elements are in place. Create and maintain 24/7 Inspection readiness at sites. Requirements and Qualifications: masters Degree in Chemistry, Pharmacy or relevant life scientific field is required Ph.D. in a related discipline would be an asset Industrial Experience Knowledge: A minimum 25+ years of experience in a pharmaceutical quality management leadership role, inclusive of directing and controlling multi-site operations and activities across multiple geographic regions with good exposure of Quality and manufacturing operations is required. A strong knowledge of GMPs in both domestic and international regulatory environments is required. Excellent and detailed knowledge of Quality/Compliance processes and programs for development and commercial products including regulatory requirements on a global level; working knowledge of safety and environmental regulations and guidelines are also required. A proven ability to lead, manage and motivate people with a variety of skill sets is required. Strong organizational, interpersonal and communication skills are essential. Excellent negotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders. Ability to work effectively in an international multicultural matrix organization is strongly preferred.
