Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: India Bio Quality Hub Leader
Job Description:
Job Purpose:
Responsible for quality assurance oversight of contractors that manufacture or package Pharmaceutical products for Pfizer. The incumbent will be an integral part of the country HUB Team, and will actively partner with country and regional hubs, QA and Specialty Biotech Business unit to ensure effective oversight, direction and compliance at the contractor.
This position will have responsibility for all aspects of GMP Quality Operations and Quality Systems oversight at manufacturing sites with the country HUB. These responsibilities include QA oversight of manufacturing, validation and testing operations at the third party contractor, batch release, day to day oversight and inspection support. He/she will ensure the effective implementation and maintenance of Quality Systems that are aligned with Pfizer standards, appropriate industry standards and appropriate global regulatory expectations.
Reporting Structure:
This position will report to the Senior Director/Team Leader, Biotech COQA. The position will also have regional alignment via COQA Asia Pacific and partnership/technical alignment with the EM Quality Hub leader
Job Responsibilities:
• Interacts professionally with company management, internal departments, third parties and other sites to provide effective QA oversight and guidance. Partners with peers within the HUB to ensure that SOP's are in place and followed and ensures timely problem resolution
• Partners with peers to drive the development, implementation and continuous improvement of Quality Systems, such as documentation, disposition, deviations, CAPA, complaints and change controls. Ensures that appropriate site policies, SOP's and documentation are in place to support Quality Systems according to regulatory requirements and current industry standards.
• Represents contractor Quality within the HUB, ensure the development and maintenance of information systems for tracking and trending pertinent data for quality system performance and/or improvements. Prepares metrics and summaries to effectively communicate status and recommendations to Senior Management.
• Provides leadership for significant deviation events or failure investigations at contractor sites that may impact compliance status or require regulatory notifications. Ensures implementation of corrective actions and quality system improvements based upon remediation activities determined.
• Responsible for the disposition of clinical and commercial products. Ensures appropriate quality system controls to ensure correct distribution of product given pending CMC submissions and approvals
• Will support the review of CMC analytical testing documentation in support of formulation development, clinical product manufacture and commercial products, including release, stability, method validation and process validation testing.
• Partners with HUB members and Quality to implement inspection readiness activities. Reviews inspection responses and remediation plans for acceptability while ensuring tracking of corrective actions to closure. Ensures that post inspectional commitments are tracked and completed on time
Job Profile:
• A Bachelors degree in microbiology, chemistry, pharmacy or a related science.
• 15 or more years in a GMP Quality function with increasing levels of responsibility
• Deep understanding of Biotechnology products and in-depth knowledge of manufacturing and quality regulations
• Excellent communication, and influencing skills, able to interact effectively at a senior level across functions and companies.
• Strong leadership, interpersonal, and team building skills
• Strong written and verbal communication skills
• Knowledge of local culture and command of local language is preferred
• Highly committed, demonstrating patience, enthusiasm and energetic approach to the role.
Personal Characteristics:
• Able to lead key initiatives, motivates team to work collaboratively to achieve objectives. Maintain focus on key priorities.
• Establishes clear expectations and priorities. Flexible and creative problem-solving skills. Very decisive and action oriented.
• Able to contribute to strategy development. Demonstrates creativity and effectively addresses strategic challenges. Capable of thinking out of the box and taking risks.
• A team player who works effectively in a team-based organization. Exercises influence at senior levels and builds alignments around goals and objectives.
• Able to convey complex concepts and strategies. Effectively manages meetings and possesses strong presentation skills.
Additional Information:
Location: India
Education: B.Pharm, B.Sc - Microbiology, Chemistry
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Quality
Job Id: 949696
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