Biocon - Lead CQA - QMS & Governance

RESPONSIBILITIES:

STRATEGY - Perform activities as per organizational core values demonstrating high standards of integrity and ethical behavior at all times. Identify opportunities and enhance processes to strengthen Quality Management Systems continually. Own and lead initiatives identified for enhancing organizational Quality Culture and Mindset. Lead Quality Management aspects on all GXP-regulated digitalization endeavors. Stay abreast of regulatory changes in the industry and implement technical and sustainable GXP Quality Management solutions. Harness internal audits and inspection findings to identify opportunities for strengthening the Quality System Framework. Ensure all-time inspection readiness.

OPERATIONS - Own the GXP Business Processes on Quality Management Systems including quality management, document management, and other enterprise systems. Ensure processes and procedures implemented are harmonized across Biocon Biologics and that they conform with the current GXP regulations.

- Define, measure, monitor, and periodically report metrics related to Quality Management, Vendor Management, Learning Management, Audits Management, etc. Communicating Audit Observations and CAPAs to all sites, to share learning across sites.

- Propose preventive measures and promote and implement improvement programs. Ensure Quality System activities are managed as per their schedule. Support technical troubleshooting of QMS, DMS, and other enterprise systems and support managing the application life cycle as per organizational procedures. Support the implementation of enterprise IT systems. Implement a business continuity plan for the teams managed which is fit for execution, as situations arise. Coordinate Medical devices / Combination products certifications (e.g., ISO 13485) - design control quality, and quality system implementation. Provide necessary support and expertise to all sites and projects concerning matters of Quality. Prepare and coordinate management review meetings for Quality Systems.

- Prepare and coordinate management review meetings for Quality Systems Offer flexibility for travel across the organization to support activities required by the business. Plan capital expenses and operational expenditures and propose expenses anticipated in the annual departmental budget. Ensure that the operational expenditures are regulated and are within the budget allocated for the Corporate QA Team. Participate in cost improvement endeavors to optimize budget utilization balancing volume and efficiency targets in line with business objectives. Adhere to the principles of EHS and contribute towards a safe workplace. Comply with all organizational statutory compliance requirements.

- Perform any other administrative duties assigned. PEOPLE Champion the organizational core values. Respect diversity and promote inclusivity to develop an efficient team. Coach, nurture, and mentor talent and strive towards achieving success in a quality-compliant manner through guidance and direction.

- Hire, train, and develop people in line with pertinent requirements of Corporate Quality functions from time to time. Identify learning opportunities to enhance the skillsets and capabilities of the team. Identify opportunities for improving individual efficiencies and alleviate challenges through continual feedback. Ensure adequacy of manpower and resources for business continuity. Communicate to collaborate and ensure healthy working relations with all personnel including cross-functional teams.