ESOQ Contractor Stability Lead, Manager

Pfizer • Lake Forest, IL

4d • Onsite

About The Position

Use Your Power for Purpose As a Manager, ensures oversight over stability activities for contract manufacturing organization (CMO) and contract testing organizations (CTO) within the ESOQ organization. Independently works with CMOs/CTOs to ensure all stability commitments are met. Assures that submission-ready stability protocols and reports are prepared. Provides quality and stability oversight for Pfizer products manufactured at CMO and tested at CTO to ensure compliance with GMP regulations and quality agreements. Actively contributes as part of the ESOQ Tier 2 structure to ensure that Pfizer network of External suppliers / CMO’s / partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/ applicable GMP/GDP regulations. What You Will Achieve In this role, you will:
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). Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity. Lead and support continuous improvement efforts, where applicable. Be a role model to support a positive compliance culture. Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data integrity principles. Able to perform statistical analyses and prediction interval projections at the end of the product shelf-life period to anticipate potential out of specification or trend. Able to analyze data in JMP, SAS, Minitab or any other statistical software in use at Pfizer Provide consultation on issues to Pfizer ESOQ in connection with Stability trending and Regulatory filing of Stability data. Stay current with ICH requirements for trending methodology for stability and its applications pertinent to the Pfizer business needs. Be up to date on training and compliance with all Pfizer SOPs as required based on the assigned curriculum.

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.
• Communicates well verbally and in writing
• Responds fully and to the correct audience in a timely manner
• Aptitude for computerized systems required
• Able to manage a heavy workload and short turn times with agility and optimism
• High proficiency in Microsoft applications such as Teams, Word, Excel, Visio, Outlook, and PowerPoint
• Knowledge of pharmaceutical stability operations and associated industry regulations including cGMP, 21 CFR, ICH, and other global regulations highly desirable

Nice To Haves

• Previous experience with stability administration strongly desired.
• Working knowledge of Laboratory Information Management Systems (LIMS)
• Familiarity with document management systems (Veeva, GDMS) and Quality Tracking Systems (gQTS/TrackWise/Veeva) highly desired
• Basic knowledge of Bayesian statistics and high-performance computing

Responsibilities

• 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).
• Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
• Lead and support continuous improvement efforts, where applicable.
• Be a role model to support a positive compliance culture.
• Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data integrity principles.
• Able to perform statistical analyses and prediction interval projections at the end of the product shelf-life period to anticipate potential out of specification or trend.
• Able to analyze data in JMP, SAS, Minitab or any other statistical software in use at Pfizer
• Provide consultation on issues to Pfizer ESOQ in connection with Stability trending and Regulatory filing of Stability data.
• Stay current with ICH requirements for trending methodology for stability and its applications pertinent to the Pfizer business needs.
• Be up to date on training and compliance with all Pfizer SOPs as required based on the assigned curriculum.

Benefits

• In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program.
• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED