Site Quality Systems Lead (Secondment 12 Months)

Pfizer•Sanford, NC

1d•Hybrid

About The Position

WHY PATIENTS NEED YOU The QO Systems Lead is responsible for the operational and strategic management of Quality Systems. The QO Systems Lead ensures that the Validation, Change Control, Training, Documentation, Applications, and Human Performance programs comply with cGMP standards and corporate quality standards, while partnering with site management team to effectively design, develop and implement processes to support business goals and site strategies. This position will be a member of the site Quality Leadership team (QLT) and will report to the Site Quality Operations Leader (SQOL). WHAT YOU WILL ACHIEVE Provide operational and strategic leadership to QO Systems teams to define goals & objectives and drive performance. Ensuring adherence to applicable regulations and Pfizer Quality Standards. Ensuring the Quality system requirements are effectively established and monitored. Build Quality into the product transfers to ensure high quality product is consistently manufactured and tested per validated processes. Holds self and the team accountable for making decisions, deriving solutions or driving improvements for the areas in scope. Partner with stakeholders to improve and sustain metrics through continuous improvement. People development – coach and mentor team to demonstrate excellence. Build the culture of active learning inculcating the Pfizer value of “Joy”. Represents the site Quality Systems team in limited duration teams, cross-departmental/cross-site/cross-network meetings as needed and able to carry out activities as requested by the Site Quality Operations Leader. Responsible for role modeling, coaching and ensuring others embody Pfizer values and behaviors.

Requirements

Applicant must have a bachelor's degree with at least 8+ years of experience; OR a master's degree with at least 7+ years of experience; OR a PhD with 5+ years of experience.
Manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS Degree in Sciences or Engineering.
Previous leadership experience required, and experience in leading people leaders and directing organizations.
Knowledge and experience in Quality Systems – Deviations, Change controls, CAPA, Validation, Change Control, Training, & Documentation control.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Nice To Haves

Experience supporting Board of Health inspections.

Responsibilities

Provide operational and strategic leadership to QO Systems teams to define goals & objectives and drive performance.
Ensuring adherence to applicable regulations and Pfizer Quality Standards.
Ensuring the Quality system requirements are effectively established and monitored.
Build Quality into the product transfers to ensure high quality product is consistently manufactured and tested per validated processes.
Holds self and the team accountable for making decisions, deriving solutions or driving improvements for the areas in scope.
Partner with stakeholders to improve and sustain metrics through continuous improvement.
People development – coach and mentor team to demonstrate excellence.
Build the culture of active learning inculcating the Pfizer value of “Joy”.
Represents the site Quality Systems team in limited duration teams, cross-departmental/cross-site/cross-network meetings as needed and able to carry out activities as requested by the Site Quality Operations Leader.
Responsible for role modeling, coaching and ensuring others embody Pfizer values and behaviors.