Endo · 11 hours ago
Manager Quality Control
Raleigh, NC
Full-time
Onsite
Mid, Senior Level, Lead/Staff
10+ years expEndo is a leading healthcare company committed to improving lives through quality and safety. The Quality Control (QC) Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards, managing QC laboratories, and leading compliance with Good Manufacturing Practices (GMP).
Pharmaceuticals
Responsibilities
Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines
Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications
Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements
Maintain accurate records of all QC activities, including test results, deviations, and corrective actions
Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality
Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA)
Prepare for and participate in internal and external audits, including regulatory inspections
Oversee calibration, validation, and maintenance of laboratory instruments
Provides subject matter assistance for LIMS, methods, testing, and validation
Manages QC testing group to achieve compliant testing in a timely manner
Manages Lab investigations and OOSs including remediation of potential compliance concerns
Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement
Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation
Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions
Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations
Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades
Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory
Ensures key turnaround timelines for customer service and compliance requirements are achieved
Performs as a subject matter expert during customer and regulatory audits
Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle
Develops and coaches to build talent
Participate in a 5S Workplace System to ensure good housekeeping and organization
Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy
Effectively trains others in a positive manner
Other duties as assigned with or without accommodation
Qualification
Required
B.S. /B.A. in Physical Science required
Preferred
Master's Degree preferred
10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements
Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories
Experience With Testing API Or Pharma Products
Experience leading a group of up to 20 people with 24/7 shift operations
Excellent Written And Verbal Communication And Leadership Skills
Ability to work in and promote a team environment
Working knowledge of Six Sigma and/or Lean manufacturing tools
Sense of urgency
Action oriented/drives for results
Excellent Communication And Interpersonal Skills
Team orientation/strong team player
Ability to coach, mentor and teach
Excellent Decision Making, Problem Solving And Analytical Skills
Strong managerial courage
Ability to influence change at all levels of the organization
Detail-oriented with the ability to work under tight deadlines
Excellent Conflict Management Skills
Builds positive relationships with others
Excellent Time Management And Prioritization Skills
Excellent technical writing skills
LIMS Experience Preferred
Knows the difference between managing and leading and when to apply each
Command Skills, Action Oriented, Conflict Management, Customer Focus, Problem Solving, Priority Setting, Written Communication
Company
Endo
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
Founded in 1997Malvern, , US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Blaise Coleman
President and Chief Executive Officer
Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
Recent News
2025-09-23
2025-09-22
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