Regional QO Support Leader, LSM (12 months secondment)

POSITION SUMMARY

The Quality Operations (QO) Regional Support Leader will work in conjunction with the Operating Unit (OpU) Quality Operations Leader to provide support to LSM sites. The incumbent will work closely with OpU Quality Leaders, Site Quality Operations Leaders, and other Pfizer Global Supply (PGS) site colleagues to facilitate improvement in site quality and compliance performance, support effective issue resolution, support development of high-quality investigation and finalization of audit responses. The incumbent will also help drive improvements, leverage best practices across the network, and will facilitate enhanced quality culture and site compliance.

POSITION RESPONSIBILITIES

• Supports QO leaders for identifying priorities and ensuring the right quality culture at the site and resolving high priority quality issues
• Facilitates the timely and appropriate resolution of assigned quality issues.
• As needed, develops, and ensures implementation of quality improvement plans at sites.
• Provides support to site inspection readiness programs, supports assessment of gaps and identification of appropriate CAPAs, ensures right governance is in place and follow up on dashboards.
• May periodically act as a backup for the OpU Quality Operations Leader, on an as needed basis.
• Reviews and ensures the development of high-quality Area Quality Review Team (AQRT) executive summary documents as assigned.
• Ensures regulatory agency and RQA responses are appropriate in content and are well written.
• Ensures that significant deviations/complaints are well investigated and appropriate CAPAs have been assigned.
• Ensures SQRT forum is used effectively.
• As need, support the development of the Quality and Compliance Maturity Assessment (QCMA) and support reducing the risk of the high-risk elements.
• Lead/coordinate cross LSM sites initiatives

ORGANIZATIONAL RELATIONSHIPS

Op U Quality Operations leaders, Site QO leaders, Site Leaders, Center SMEs

Qualifications

• Bachelor/Master degree in Pharmaceutical Science, Microbiology, Chemistry or equivalent.
• Minimum 10 years experience in the pharmaceutical industry, including commercial manufacturing expertise with a thorough understanding of quality systems and compliance requirements.
• Demonstrated experience in quality decision-making in a complex environment.
• Additionally, the successful candidate must be flexible with regard to changing and conflicting priorities, able to easily shift gears in terms of behavior and attitude in response to ambiguity and the needs of the situation.
• The ability to communicate effectively at all levels of the organization.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, and develop and coach others.

Work Location Assignment:Remote

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