Job description

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

What You Will Achieve

In this role, you will:

Be responsible for approval and delivery of regulatory stability reports and protocols.
Be responsible for ensuring that all required external testing at Contract Testing Labs (CTLs) are completed following all cGMP and internal requirements for quality and timeliness.
Ensure stability studies at CMO/CTL 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/CTL quality and compliance risks, ensuring CMO/CTL 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.
Provide statistical advice on complex statistical problems arising in Pfizer projects.
Able to perform statistical analyses and prediction interval projection 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 statistical issues to Pfizer ESOQ in connection with Stability trending and Regulatory filing of Stability data.
Participate actively in discussions towards key go/no decisions, key regulatory and product defense strategies.
Stay current with research on statistical methodology 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.

Here Is What You Need (Minimum Requirements)

BA/BS or advanced degree in Chemistry, Biology with at least 8-10 years of experience in the pharmaceutical industry or PhD with at least 6 years of experience in the pharmaceutical industry
Substantial experience in pharmaceutical quality control and stability management
Familiarity with cGMPs and applicable stability regulations and guidelines (e.g. CFR, EMEA and ICH publications)
Knowledge of regulations related to vendor management programs / Contract Testing Labs and other industry quality systems
Strong critical thinking skills and a proactive approach
Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
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
Working knowledge of Laboratory Information Management Systems (LIMS)
Familiarity with document management systems (Veeva, GDMS) and Quality Tracking Systems (gQTS/TrackWise/Veeva) highly desired

Bonus Points If You Have (Preferred Requirements)