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Pfizer · 15 hours ago

QA Manager - Investigation Review

North Carolina, United States

Full-time

Onsite

Mid, Senior Level

$99K/yr - $160K/yr

4+ years exp

Pfizer is committed to delivering safe and effective products to patients through a strong focus on quality. In this role, you will lead moderately complex projects, ensure adherence to manufacturing specifications, and guide teams in quality control and compliance activities.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

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

Qualification

Pharmaceutical manufacturingQuality controlCurrent Good Manufacturing Practices (cGMP)Vendor management regulationsQuality systems experienceData science knowledgeAdvanced MS Office skillsInternal audits experienceAI tools experienceCritical thinkingLeadership skillsTeam managementCommunication skillsNegotiation skills

Required

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 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 a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms

Preferred

Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

Knowledge or exposure to data science

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 common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use