Pfizer

Contractor Stability Lead, Manager

Pfizer

full-time

Posted on:

Location Type: Office

Location: Lake Forest • Illinois • United States

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Salary

💰 $99,200 - $160,500 per year

Job Level

Senior

About the role

  • Approve and deliver regulatory stability reports and protocols.
  • Ensure that all required external testing at CTOs are completed following all cGMP and internal requirements for quality and timeliness.
  • Ensure stability studies at CMO/CTO sites are conducted according to approved protocols and ICH guidance.
  • Serve as stability SME for investigations and stability administration document approvals.
  • Manage all required activities to support external testing of stability studies.
  • Trend stability results to support product expiry and expiry extensions.
  • Author stability related sections in regulatory submission, including responses to questions and post-marketing commitment support.
  • Utilize risk management tools to identify and migrate CMO/CTO quality and compliance risks, ensuring CMO/CTO sites are in a state of continuous inspection readiness.
  • Provide as needed support during regulatory inspections and compliance audits for stability management activities.
  • Focus on Safety and GMP compliance as operational priorities and as performance measures that should be included in metrics.
  • Know the processes and global stability procedures and being accountable for the principles and practices of good documentation and data management/data integrity (ALCOA).

Requirements

  • BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience in Chemistry or Pharmacy.
  • Demonstrates strong technical/functional knowledge needed to coach direct reports on day-to-day activities.
  • Strong communication (oral and written) and teamwork skills.
  • Demonstrated critical thinking skills; close attention to detail and accuracy and ability to work both independently and in a team environment.
  • Self-motivated and willing to learn new and changing responsibilities; agile response to constantly changing conditions and priorities.
  • Demonstrated commitment to values-based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core Competencies.
Benefits
  • 401(k) plan with Pfizer Matching Contributions
  • Additional Pfizer Retirement Savings Contribution
  • Paid vacation
  • Paid holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits including medical, prescription drug, dental and vision coverage
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory stability reportscGMPICH guidancestability studiesrisk management toolsdata managementdata integrityALCOAregulatory submissionquality compliance
Soft Skills
communicationteamworkcritical thinkingattention to detailself-motivatedagilityvalues-based leadershipcoachingindependenceadaptability