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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Bangor | Brewer |Maryland :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Hebron | Nebraska City |Nevada :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Halle |Schleswig Holstein :
Kiel |Belgium :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Hubei :
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Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
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Canada |Ontario :
Renfrew | Richmond Hill | Uxbridge | North York | Australia | Mississauga |Quebec :
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