Manager Quality Control

Endo Pharmaceuticals•Raleigh, NC

40d

About The Position

The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing.

Requirements

B.S. /B.A. in Physical Science required.
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
Excellent written and verbal communication and leadership skills
Ability to work in and promote a team environment
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
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

Nice To Haves

Master's Degree preferred.
Experience with testing API or Pharma products
Experience leading a group of up to 20 people with 24/7 shift operations
Working knowledge of Six Sigma and/or Lean manufacturing tools
LIMS experience preferred

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.