Pfizer Quality Event (CAPA) Manager in Collegeville, Pennsylvania
Pfizer is excited to present an opening for a Quality Event Manager. In a highly visible and global facing role, the incumbent will support the management of deviations within the Quality Management System (QMS) process for Worldwide Medical & Safety (WMS) including qualification and/or triage of significant quality events within WMS.
The QE Manager is responsible for supporting Quality Event/CAPA Owners in performing investigations and driving each event to conclusion by working with Business Process Owners (BPOs), business lines, quality groups and governance groups to enable and promote quality, accountability and effective delivery of CAPAs and Commitments across WMS.
The QE Manager ensures the investigation outcome, root cause analysis, and resulting solutions (CAPAs) are completed in a timely and effective manner, in compliance with standards. The robustness, rigor and speed demonstrated by the QE Manager will drive a culture that prevents unplanned deviations through a robust and proactive investigation process.
Support the management of quality events within WMS
Assess all Quality events received within WMS
Ensure appropriate assignment of all CAPAs associated to PV activities by Pharmacovigilance Quality (PVQ) including identification of appropriate business line lead and business line quality group lead in consultation with business process owners.
Perform Quality Checks on WMS CAPAs to ensure completeness and inspection readiness
Provide support to CAPA and Commitment Leads/Owners and serve as conduit between BPOs, business lines, quality groups and governance groups to enable and promote quality,
Accountability and effective delivery of CAPAs and Commitments
Act as the PVQ partner to facilitate progress and close CAPAs and commitments arising from regulatory inspections and internal audits, as appropriate.
Participate in/facilitate continuous improvement processes to optimize the PV quality system and keep it current, based on applicable worldwide regulations.
Provide inspection and audit support as appropriate in consultation with business process owners. Provide appropriate mentorship of business line quality leads to support CAPA management and documentation
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.
BS with 9+, MS with 7+, PhD with 4+ years' minimum experience focusing on Pharmacovigilance, Regulatory Affairs, Quality Management, CAPA Management or within a Health Authority.
Extensive knowledge of the pharmaceutical industry including Pharmacovigilance and ICH compliance regulations and guidelines and expertise within the pharmacovigilance, inspection, audit, or quality and compliance arena
Demonstrated awareness of the key differences in how business is practiced in various countries to work effectively with various cultures. It is essential to be aware of the key cultural customs and practices that will create an effective working relationship with internal and external partners and effectively represent Pfizer as a multinational organization.
- Experience using continuous improvement techniques (for example, Six Sigma, Root Cause Analysis) to investigate quality issues, develop action plans and implement improvement solutions
Other Job Details:
Last Date to Apply for Job: December 15th, 2021
Additional Location Information: New York, NY; Collegeville, PA; Groton, CT, Peapack, NJ; Milan, Italy
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
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