The Head of Global Quality (GQ) CC at Hyderabad is an extended member of the Global Quality Leadership Team (GQLT) and BMS GPS India leadership team. As such, this position is accountable for the sustained health, growth and continuous improvement of the global capabilities for Global Quality in India, inclusive of developing effective partnerships with critical stakeholders across BMS India, GPS, Global Quality, and R&D. This role contributes to setting the strategic direction of Global Quality within Hyderabad, in partnership with the GQLT, and focusing on building the organization through leading the acquisition, development and retention of talent, driving quality, compliance and process excellence within the GQ team at Hyderabad and the broader Global Quality organization, ensuring compliance with regulatory, corporate and departmental requirements and policies.
- Responsible for managing the Global Quality organization based in Hyderabad ensuring that the organization is aligned with Global Quality strategy, goals and standards
- Serve as an extended member of the Global Quality Leadership Team and BMS Hyderabad CC Leadership Team translating company and departmental strategies into organizational goals and objectives
- Direct all aspects of site quality programs, systems, operations and compliance activities at Hyderabad in alignment with global QMS.
- Ensure GxP required procedures are in alignment and compliance with BMS Corporate Policies and Procedures
- Drive operational excellence within the GQ organization based in Hyderabad by building an organization aligned to the Global Quality culture
- Partner with GQ Leadership Team to develop the People Strategy for Hyderabad and effectively recruit, manage, develop, evaluate, reward and retain the GQ organization in Hyderabad resulting in an increasing level of capabilities
- Create, maintain, improve, and innovate processes to increase productivity and quality for the quality management system
- Collaborate with remote teams across different time zones and be flexible with availability
- Ensure seamless communication and collaboration between the center and colleagues located at other sites
- Manage the GQ Hyderabad budget to meet financial objectives
Qualifications & Experience
- Graduate degree
- Minimum of 12 years experience in quality organizations, experience managing a global capabilities organization is preferred
- Minimum of 5 years experience in managing people and growing teams
- Experience with leading quality systems such as product complaints, document management, CAPA and/or computer systems validation
- Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations and understanding of quality risk management (ICH Q9) concepts
- Familiarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes
- Demonstrated ability to operate and lead in a global matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs
- Demonstrated ability to interact successfully with senior business partners both internal and external to the company
- Successful demonstration of compliance leadership effectiveness in quality assurance and compliance in a global regulatory environment
- Demonstrated success as a strong team leader who uses past supervisory experience to develop departmental staff through effective feedback and coaching
- Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, including the ability to deliver clear and articulate presentations
- Commitment to Quality