QA Specialist Lead; 2nd Shift

Overview

We’re in relentless pursuit of breakthroughs that change patients’ lives. Pfizer Global Supply manufactures and distributes our pharmaceutical products. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our commitment to quality ensures the delivery of safe and effective products to patients, supported by a culture rooted in science and risk-based compliance.

Every day, our work contributes to patients through development, maintenance, compliance, or analysis in pursuit of Breakthroughs that change patients’ lives.

• 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
• Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management
• Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills
• Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups
• Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs
• Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues
• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues

• BA/BS with at least 4 years of experience or MBA/MS with at least 2 years or PhD/JD with any years or associate’s degree with at least 8 years or high school diploma (or equivalent) with at least 10 years of relevant experience
• Substantial experience in pharmaceutical manufacturing and 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
• Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
• Advanced computer skills in MS Office applications and familiarity with enterprise systems such as PDM, Trackwise, and Documentum

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Experience in conducting internal audits and supporting regulatory inspections
• Experience using AI tools to support problem solving and productivity, with awareness of responsible AI practices

Specific gowning requirements; ability to reside in a controlled environment for more than three hours; ability to stand for more than one hour.

2nd shift, 3pm–11pm, Monday–Friday with flexibility to support business needs. Relocation assistance available.

The annual base salary ranges from $99,200.00 to $. Eligible for Pfizer’s Global Performance Plan with a bonus target of 12.5% of base salary and participation in long-term incentives. Benefits include healthcare, retirement plans, paid time off, parental leave, caregiver leave, and more, with specifics by location. Relocation assistance may be available based on business needs.

Sunshine Act disclosures, EEO & Employment Eligibility information, and accessibility contact details are included in the original posting where applicable.