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Quality Support Leader AsiaPAC


Paso Robles, CA 93446
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Job Details

This role will work in conjunction with the Operating Unit Quality Operations Leaders (OpU QOLs) to provide quality support to a range of PGS sites located in the AsiaPAC region (LMS, GSM, and API) as appropriate. The incumbent will provide guidance, direction, coaching and input as needed on specific quality system design and organizational enhancement pertinent to achieving effective quality and compliance. This position will work closely across the respective site Leadership teams and their direct reports, as well as liaising closely with the Op U QOL, site QO Leader, and other Center QO colleagues. The relevant OpU QOLs will maintain accountability for ovesight of each site's quality performance and for the engagement with OpU Leadership on overall performance and support requirements.

+ Support site Quality improvement plans and resolution of key investigations

+ Drive quality aspects of select manufacturing/quality issues to conclusion.

+ Ensure regulatory agency and internal audit responses are appropriate in content and are well written

+ Support investigation and identification of corrective actions through own subject matter expertise or in collaboration with other quality SMEs as needed.

+ Communicate status, resource needs and outcomes to site and quality leadership

+ May lead cross-disciplinary teams working on issue resolution or initiatives, as assigned

+ Provide coaching to colleagues regarding investigation processess, product impact assessments, quality risk assessments, process validation, NTM etc.

+ Facilitate successful and timely execution of improvement plans, through providing input to key aspects of the plan and mentoring collaegues for timely execution of plan.

+ Develop site colleagues in their understading of PQS requirements and provide advice and coaching on the effective implementation of PQS requirements.

+ Identify opportunities to enhance site Quality systems in a resource efficient manner, review this for feasibility with SLT and OpU QOL.

+ Aid in implementation of changes pertaining to quality and compliance enhancement.

+ Identify and propose to OpU QO Leaders any identified opportunities to leverage best practice and talent/SMEs across sites

The position requires up to 35% travel

+ Minimum B.Sc. in a scientific or related discipline

Minimum of 10 years' experience in Pharmaceutical quality roles, ideally 5 in quality leadership roles

+ Strong knowledge of quality and compliance requirements

+ Proven leadership skills and ability to achieve results through others

+ Good coaching skills

+ Ability to drive change and positively influence others

+ Good financial and business acumen

+ Excellent interpersonal skills including a demonstrated ability to influence and participate in teams at all levels of management

+ Leadership, integrity, team orientation, flexibility, creativity, experience in projects that require collaborative approaches, strong analytical skills and a solid ability to understand business issues and processes

+ Very strong communication and report preparation skills

Tenacity and determination

Flexi Work - Tuas (Singapore)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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