Pfizer Site QO Leader in Chennai, India
The Site Quality Operations Leader is responsible for providing leadership in assuring that appropriate systems and processes are in place at the Manufacturing Site to meet or exceed the requirements of Pfizer and the regulatory authorities for the quality of the products manufactured on site or by approved vendors. This position has a dual reporting relationship, both to the Site Leader and to the Vice President, Quality Operations; and is a member of the Manufacturing Site Leadership Team. Key focus areas and responsibilities for this position include: Overseeing all Quality Operations/Assurance functions and Site Quality Review Team (SQRT); Planning, implementing and achieving Site Quality Operations objectives consistent with Site Objectives and Global Quality Operations objectives; Providing leadership, development and direction to the Quality Operations/Assurance team; Interfacing with global
regulatory agencies. The Site Quality Operations Leader will lead, manage and develop a diverse team of talented and engaged technical professionals with the responsibility of providing comprehensive support and guidance to all operations at the site in assuring Pfizer's Quality Standards are met.
This position will:
1) Identify quality, process, and GMP problems and assure resolution.
2) Manage overall process in evaluating site compliance to Pfizer Quality Standards (PQS) and implement appropriate actions.
3) Manage the overall assurance and disposition of products produced at the manufacturing site or by approved vendors.
4) Approve quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications.
5) Review key quality and regulatory documentation and implement appropriate actions.
6) Lead and engage the site quality review team (SQRT) and AQRT process to ensure site regulatory compliance to ensure marketed product quality. Responsibility for site regulatory inspections.
7) Coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues. Manage talent development to assure adequate current capabilities and future succession for critical positions.
8) Develop and maintain an organizational structure consistent with the area needs and goals, including the preparation
and administration of annual performance assessments and discussions.
9) Optimize site effectiveness and efficiency to ensure site performance goals are achieved or exceeded without compromising quality and compliance.
11) Provide strategic leadership to QO and to the site on quality.
12) Be a voice for change and continuous improvement.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.