Quality Director

Job content

This position is based in Dharuhera, Haryana site and will be responsible to lead quality function, management of QC/QA/QMS/regulatory/Customer Interface/Technical Engineer activities, and responsible to handle regulatory inspection from Global Agencies (FDA, MHRA, TGAA, WHO).

Key Responsibilities:

• Overall responsibilities over the Quality activities of the site, managing and leading the department. The role is a member of the Site Leadership Team and reports solid line into the Global Head of Quality function.
• The role plays a critical part in establishing the quality functions, labs & equipment at the site and its preparedness for cGMP product development to commercial production. The role ensures establishment of procedures, policies and practices in full compliance and consistency with company’s global quality standards and national cGMP requirements.
• Provide lead to the quality departments to ensure that manufacturing operations are conducted at high quality and in compliance with current Good Manufacturing Practices (cGMP).
• Responsible to prepare a strategic long-term plan to further strengthen the Quality system in the organization.
• Responsible to prepare the yearly quality plan, taking local and global requirements into account.
• Responsible to translate all the relevant Global Quality standards into the Organization.
• Responsible to build a strong team of professionals and ability to lead them to ensure that all facets of quality, like Assurance, Control, documentation, Vendor Audits, Customer Audits are handled with required rigor.
• Lead the Quality Control Department and is responsible for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, validation/transfer, laboratory information and sample logistics.
• Lead the Quality Assurance Department and assume responsibility for batch release and complaint handling.
• Responsible for the development and implementation of a Quality Control strategy to meet business goals.
• To evaluate and prioritize quality projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives.
• To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy.
• Key Management Personnel position in line with GMP requirements and provide overall management and leadership for the GMP Manufacturing.
• Foster a safe and compliant culture in the workplace.
• Define and control headcount and schedule to ensure the provision of adequate resources in the quality function within budget.
• Prioritize activities as required to ensure that critical business activities occur on time
• Work together with Operations, Engineering, Validation, and MSAT to ensure all aspects of cGMP are being maintained within the Production group.
• Ensure that objectives, development plans, GMP training, succession, and talent management plans are in place for all direct reports.
• Ensure that the Quality staff operate efficiently and safely and by the requirements of Good Manufacturing Practice cGMP
• Act as a senior management representative of the Haryana site at various Customer meetings and Steering teams, including Participation in Customer and Regulatory audits as required and review and approval of critical quality records
• Build rapport with Production and line functions so that they see Quality as an enabling function, and at the same time ensure that there is no compromise on quality.
• Product development support to Business development and sales team and create an Interfacing with customers for Business Growth.
• Drive the timely release of test results and approval of certificate of Analysis to support batch release.
• Ensure collaboration between quality and all other functions.
• Mentor compliance to global regulatory requirements and to ensure current status of all manufacturing and compliance related certifications.

Key Requirements:

• Masters degree with at least 15 years of relevant experience in QA/QC handling and 5 years in leadership.
• Experience in handling Regulatory Inspection from Global Agencies such as FDA, MHRA, TGAA, WHO, etc.
• Experienced in GMP requirements and provide overall management and leadership for the GMP Manufacturing.