Pfizer General Manager (GM) in Chennai, India
Reporting to the Senior Manager PEH R&D QA (Lake Forest, US), the General Manager, PEH R&D QA Leader Chennai will provide leadership and direction to the PEH R&D QA Quality Operations teams in Chennai responsible for quality oversight of activities and operations associated with the R&D portfolio of Pfizer Essential Health products, (Sterile Injectable products, Biosimilars, API and solid oral dosage forms) and will maintain and develop suitable quality systems to enable new Quality products to be brought to market rapidly, cost effectively, and in compliance with regulatory expectations Pfizer standards.
The General Manager, PEH R&D QA Leader Chennai will provide local leadership to PEH R&D QA (operational quality) teams at IKKT, SHOL and PBDC, and will also have global leadership accountability via matrix reporting arrangements. The General Manger, PEH R&D QA Leader Chennai will drive local and global alignment for quality standards and QA resource allocation across operational QA teams. The General Manager, PEH R&D QA Leader Chennai will partner closely with Quality Systems and Compliance Leader, Chennai.
The General Manager, PEH R&D QA Leader Chennai will also sit on relevant PEH R&D and Global Technical Services (GTS business teams as required, and will collaborate with colleagues in PGS and Global Quality Operations (GQO) to ensure quality oversight of development activities and readiness for the launch of products.
Roles and Responsibilities:
Provides functional leadership for operational QA for Pfizer Essential Health R&D (PEH R&D), as part of the Pharmaceutical Sciences Quality Assurance organization. Provide quality leadership for the oversight of PEH PharmSci site activities in Chennai locations (IKKT, SHOL and PBDC), including implementation of effective quality systems, maintaining high quality and compliance performance, implementing risk and science based product quality development approaches.
Manages the PEH R&D Quality colleagues across specified locations with approximately 15 colleagues reporting to the General Manager, PEH R&D QA Leader Chennai. Provides leadership, mentorship and development to a team of quality colleagues ensuring talent development, skill agility, flexibility and effective resource management. Collaborate with other PSQA Team Leaders for talent management and colleague development.
Champions change across the global PEH R&D QA organization and drives local and global alignment and collaboration.
Interfaces with PEH Pharmaceutical Sciences Leadership, Biosimilars Leadership and Global Tech Services Leadership as required on quality and compliance related matters, collaborate on improvement projects and solutions.
Interfaces with other PSQA groups to ensure that the interests of the PEH business are appropriately represented in the development of quality systems and processes for the development of new essential products. Drives resolution and alignment on quality and compliance issues with other quality groups/lines across PSQA, PGS, COQA and MSQA.
Actively monitor, report and address quality and compliance trends and issues relevant to PEH R&D, Biosimilars and GTS activities within their oversight.
Influence, monitor, and provide input into the latest quality and compliance trends and regulatory requirements in the generic and wider industry.
Minimum of BS degree or equivalent in a scientific discipline with 10 - 15 years of experience in pharmaceutical industry
In-depth knowledge and experience of pharmaceutical cGMP and the principles and concepts of relevant quality processes based on previous roles. Able to identify, communicate, and action or ensure action on quality and compliance related issues, trends and emerging regulatory requirements
Extensive knowledge and experience of global GMP and regulatory requirements related to pharmaceutical development, including FDA, HPFBI, EMA, and Japan requirements and ICH Q7 (API), Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality Systems).
In-depth knowledge and experience in pharmaceutical development, manufacturing, analytical and/or quality operations. Ability to develop and implement risk based, global quality and compliance expectations across the R&D to commercial life cycle
Working knowledge and experience with aseptic manufacturing, technology transfer, test method validation and transfer, laboratory investigations, root cause analysis, laboratory equipment operation and qualification, and statistical analysis.
Ability and skills to report into an offsite supervisor providing updates on organization and activities at the local sites.
Demonstrated ability to interact effectively with colleagues at all levels of the organization, at multiple locations, including senior internal and/or external personnel on matters often requiring coordination between organizations
Skills in planning, organization, leading teams and ability to apply skills in ambiguous situations.
Effective written and verbal communication skills, strong interpersonal, negotiation and conflict management skills.
Ability / skills to effectively lead and develop colleagues both directly and within global / matrix organizations and changing working cultures.
Global and "big picture" focus, able to implement efficient and effective systems and processes within and across organizational units, functions and sites in alignment with PSQA organization. Able to think and act strategically.
Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
Ability to develop solutions to complex problems which requires the use of ingenuity, innovation, and creativity.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.