QA Manager, Site Investigation Lead (Secondment - 6 Months)

Pfizer•Sanford, NC

15h•Hybrid

About The Position

In this role, you will conduct detailed analysis of KPIs, collaborating cross-functionally to identify process gaps and initiate improvement strategies aligned with quality and production targets. You will lead statistical trending of deviations and investigations to uncover systemic issues and inform proactive risk mitigation. You will initiate and oversee continuous improvement projects based on data trends, leveraging Lean and Six Sigma methodologies to streamline operations and reduce recurrence. You will make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations. You will utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications. You will identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management. You will prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills. You will assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups. You will support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs. You will 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. You will ensure effective internal networking to develop and maintain business partner relationships with internal colleagues.

Requirements

Bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8+ years of experience; OR a high school diploma (or equivalent) and 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, Veeva Vault, Quality Tracking System Trackwise, LIMS, SAP and Documentum platforms.
Permanent work authorization in the United States.

Nice To Haves

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.

Responsibilities

Conduct detailed analysis of KPIs, collaborating cross-functionally to identify process gaps and initiate improvement strategies aligned with quality and production targets.
Lead statistical trending of deviations and investigations to uncover systemic issues and inform proactive risk mitigation.
Initiate and oversee continuous improvement projects based on data trends, leveraging Lean and Six Sigma methodologies to streamline operations and reduce recurrence.
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.