Quality Control Project Manager

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  Medical Insurance

  
  


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  Dental Insurance

  
  


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  Vision Insurance

  
  


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  Company Paid Life Insurance 1X annual Salary

  
  


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  Voluntary Life Insurance

  
  


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  Long-Term Disability Insurance and Short-Term Disability Insurance

  
  


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  Flexible Spending Account and Health Saving Account

  
  


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  401(K) Retirement Plan

  
  


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  10 Days of Paid Time Off

  
  


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  10 Paid Holidays Annually

  
  

Position and Scope

The QC Project Manager leads and coordinates Quality Control projects and programs from initiation through completion, ensuring alignment with business objectives, customer expectations, regulatory requirements, timelines, and financial goals. The role serves as a key cross-functional liaison between QC, QA, Program Management, Finance, customers, and external partners, providing project leadership, risk and resource management, issue resolution, and performance oversight.

This role is 100% On-Site, Monday – Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:00am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• Lead end-to-end QC project management for complex pharmaceutical and biopharmaceutical programs, including project scope, timelines, milestones, resources, risks, deliverables, testing priorities, and customer commitments.


• Serve as the primary QC project lead, coordinating activities across QC, QA, Project Management, Finance, customers, and external laboratory partners to ensure timely, compliant, and efficient execution.


• Translate customer requirements into executable testing strategies, project plans, resource requirements, regulatory deliverables, and compliance objectives.


• Manage stability programs from study initiation through testing, data review, reporting, and completion, ensuring adherence to protocols, schedules, SOPs, quality requirements, and customer commitments.


• Ensure QC testing readiness across personnel, equipment, analytical methods, documentation, and laboratory systems, while proactively identifying and resolving operational risks and resource constraints.


• Participate in root cause investigations, CAPAs, change controls, remediation efforts, and continuous improvement initiatives to strengthen quality, compliance, and operational efficiency.


• Utilize project metrics to monitor performance, identify trends and resource gaps, and provide data-driven insights to support project and business decisions.


• Partner with Finance to track project activities and billable work, assign costs to appropriate customer and GL accounts, support accurate invoicing, and reconcile financial activity with approved project scope.


• Manage project governance and executive communications, including status reporting, risks, milestones, resource and financial updates, escalations, and key decisions.


• Participate in effective customer and stakeholder relationships through clear communication, alignment on requirements and deliverables, and timely resolution of project issues.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Requirements and Qualifications

• Bachelor's degree in chemistry, biochemistry, biology, pharmaceutical sciences, or a related scientific discipline.


• 5+ years of experience in pharmaceutical, biopharmaceutical, or other GMP-regulated environments, including Quality Control experience.


• 3+ years of experience in QC project management, laboratory operations, stability management, or related project leadership.


• Demonstrated experience managing multiple concurrent projects and cross-functional teams in a regulated environment.


• Strong working knowledge of GMP, QC laboratory operations, stability programs, analytical testing, data integrity, and quality systems.


• Experience with project planning, scheduling, risk management, resource coordination, and customer deliverables.


• Experience with deviations, investigations, CAPAs, change controls, and audit/inspection readiness.


• Proficiency with Microsoft Office; experience with Power BI or similar reporting tools preferred.


• Strong analytical, organizational, communication, and problem-solving skills, with the ability to work independently and effectively engage senior leadership and customers.