Job Overview
Position: WSR Quality Event Lead
Location: Parsippany, New Jersey, USA (Hybrid work arrangement)
Employment Type: Full-time
Posted: Approximately 7 days ago
Job ID: 4940475
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Mission & Context
At Pfizer, delivering medicines faster—without compromising quality or integrity—is critical. This role is integral to ensuring Pharmacovigilance (PV) operations within the Watch, Share & Report (WSR) framework uphold rigorous quality standards. You’ll help navigate regulatory expectations while maintaining a forward-thinking, detail-oriented approach.
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Core Responsibilities
Quality Event Management: Lead or support handling of deviations within WSR’s QMS (Quality Management System) as outlined in QMS 01.
Event Assessment: Evaluate all quality events, triaging significant issues and ensuring they align with process protocols.
CAPA Coordination: Facilitate the assignment of Corrective and Preventive Actions (CAPAs) tied to PV activities. Mentor business line quality leads on CAPA documentation and management.
Quality Assurance Checks: Conduct checks to confirm CAPA completeness and readiness for inspections.
Cross-functional Collaboration: Act as the link between business process owners, business lines, quality teams, and governance groups to ensure accountability and effective delivery of CAPAs and commitments.
Regulatory Follow-through: Support closure of CAPAs and commitments stemming from audits or inspections.
QMS Monitoring: Develop and enable mechanisms to monitor QMS performance, focusing on CAPA effectiveness and proactive identification of quality trends.
Trend Analysis: Support processes to collate and track inspection-related commitments to enhance system quality oversight.
Continuous Improvement: Participate in initiatives to optimize the PV quality system, ensuring regulatory alignment.
Inspection Support: Provide support during audits and regulatory inspections.
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Qualifications & Experience
Minimum Requirements:
Bachelor’s degree or equivalent required, with relevant experience in inspections, audits, quality management, or compliance.
3–4 years of experience in Pharmacovigilance, Regulatory Affairs, Quality Management, CAPA management, or within a Health Authority environment.
In-depth knowledge of the pharmaceutical industry’s PV and ICH compliance expectations.
Cross-cultural awareness to collaborate effectively in global environments.
Experience working with health authorities such as the FDA, EMA, or MHRA is highly desirable.
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Preferred Qualifications (Bonus Points):
Advanced degree (MA, MS, MBA) with 7+ years of experience, or a PhD/PharmD/JD with 4+ years relevant.
Proficiency in Lean or Six Sigma methodologies.
Strong background in continuous improvement techniques.
Excellent problem-solving, mentoring, and leadership skills.
Experience consulting on records management during drug development.
Proven capability to develop partnerships across regional, country, and functional leaders to drive efficiency.
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Compensation & Benefits
Base Salary Range: $112,700 – $187,800/year
Performance Bonus: Eligible for Pfizer’s Global Performance Plan—15% of base salary
Long-Term Incentives: Share-based incentive program access
Benefits Highlights:
401(k) with matching and additional Pfizer contributions
Paid vacation, holidays, personal days
Paid caregiver, parental, and medical leave
Comprehensive medical, dental, vision, and prescription drug coverage
Relocation Assistance: Available based on business needs and eligibility
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Compliance & Legal Considerations
Sunshine Act Notice: As required, Pfizer reports certain payments or reimbursements to healthcare providers. Recruiting-related payments to licensed physicians may be reported under the Sunshine Act.
Equal Employment & Eligibility: Pfizer is an E-Verify employer and committed to equal opportunity. Candidates must hold permanent U.S. work authorization.
Accessibility: Support is available for applicants requiring accessibility accommodations during the application or interview process (contact: disabilityrecruitment@pfizer.com).
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Summary Table
|
Category |
Details |
|---|---|
|
Position |
WSR Quality Event Lead |
|
Location & Work Model |
Parsippany, NJ (Hybrid) |
|
Core Function |
PV Quality Event & CAPA Management |
|
Qualifications |
Bachelor’s + 3–4 yrs relevant PV/Quality/Regulatory experience |
|
Preferable Expertise |
Advanced degree, Lean/Six Sigma, inspection experience |
|
Compensation |
$112,700–$187,800 base; 15% bonus; equity incentives; robust benefits |
|
Compliance Requirements |
U.S. work authorization, adherence to regulatory reporting standards |
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Rangpo |India :
Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
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Croatia |Zagreb :
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