QA Senior Specialist

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:

• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work

• Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations

• Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications

• Complete Investigations Regulatory impact and Provide oversight of complex investigations ensuring appropriate root cause analysis, scientifically sound conclusions, and effective CAPAs (including stand-alone QC CAPAs as needed)

• Independently provide Quality Review and oversight of site cGXP documentation related to the support of Quality Control labs and Operations activities to ensure compliance with global regulatory agencies and Pfizer quality standards.

• Collaborate/independently engage with a wide range of co-workers, customers and management within PGS (and external sites/CMOs as necessary) to gather the input and background knowledge needed to complete assignments.

• Anticipate issues and provide recommendations for path forward to appropriate management attention immediately.

• Perform change control impact assessments to evaluate risk, define required testing/validation, and align stakeholders on strategy.

• Review and approval of change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations. 

• Ability to review method transfers, protocols and reports and associated QC SOPs

• Ability to independently issue notifications to management for critical issues.

• Plans and executes work independently and consults with supervisor as needed, providing a recommendation for a solution. 

• Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.

• Lead continuous inspection readiness for Quality Assurance.

• Mentor junior quality colleagues on best practices and complex problem resolution to quality issues and CAPAs.

• Support Annual Product Review (APR), regulatory filings, and response to health authority queries by compiling, verifying, and summarizing quality/validation/manufacturing data.

• Support technology transfer (in/out), including readiness assessments, document transfer packages, gap assessments, and quality oversight of execution.

• Coordinate product disposition activities, partnering with Quality Control, Manufacturing, and Supply Chain to ensure timely and compliant release decisions.

Here Is What You Need (Minimum 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

• Substantial experience in pharmaceutical manufacturing and/or quality control

• Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects

• Knowledge of regulations related to vendor management programs and other industry quality systems

• Strong critical thinking skills and a proactive approach

• Strong attention to detail and documentation practices; maintains data integrity and traceability.

• Risk-based decision making and ability to identify GMP impact and escalate appropriately.

• Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally

• Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms

Bonus Points If You Have (Preferred Requirements)

• Direct experience with tech transfer activities (clinical to commercial, site-to-site, or CMO transfers).

• Experience supporting regulatory sub