Quality Control Manager

Job Code:

Q1016

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Post Date:

February 22nd, 2021

JOB DESCRIPTION

The incumbent is responsible for day to day management of the Quality Control team and is responsible for hiring, managing performance, and development of reporting staff.  The individual must have proven knowledge of Quality Control System development including creation of SOPs, Work Instructions, etc.  The individual is recognized as a subject matter expert with regard to Quality Control Analytical and Microbiology practices and procedures and serves as the main point-of-contact for all QC activities.  The incumbent is responsible for planning, scheduling, and organizing QC activities related to meeting the compliance, supply, profit plan and strategy objectives of the company and the department.  The individual initiates and oversees projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement.  The incumbent makes recommendations regarding departmental profit plan, capital planning, budget, and standards development.  In this role, the individual must be able to identify and communicate improvement opportunities and results.  The incumbent identifies operational needs for projects, ensuring site/divisional linkage is achieved.  The incumbent must be able to identify and address short term, intermediate, and long term issues, and be able to appropriately resolve conflict and prioritize work as necessary.  This role may have individual contributors and/or hourly support staff reporting to them.

RESPONSIBILITIES

  • Responsible for all activities related to the Quality Control group including QC Analytical and QC Microbiology. 

  • Responsible for creation of all QC Analytical and QC Microbiology quality systems and implementation of those systems.

  • Management of test method transfer to QC teams

  • Responsible for leadership of analytical method development, validation, and stability evaluations of drug products. 

  • Collaborate with cross-functional teams to resolve complex method development challenges.

  • Direct, develop and evaluate team members to assure all individuals in the Quality Control group reach their potential.

  • Responsible for coordinating the Quality Control Budget.

  • Responsible for participation in internal audits, client audits and agency inspections of the site which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties. 

  • Responsible for development of phase-appropriate QC capabilities, business processes, and procedures.

  • Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including oversight of cGMP sample handling, testing, QC release and stability data analyses and method data trending, out of specification investigations, and Certificates of Analysis creation.

  • Oversee and manage method validation, transfer, and testing.

  • Oversee contract QC laboratories including routine performance management and participating in audits to ensure sustained quality analytical deliverables.

  • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure the QC function remain in compliance with applicable company requirements and global regulations.

  • Other duties as assigned by the Sr. Director of Quality and Regulatory Affairs.

QUALIFICATIONS

  • BS/BA in sciences, preferably in chemistry, biochemistry, microbiology, biotechnology, pharmaceutical sciences, or related technical field.

  • 10+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.

  • Manager of Quality/Organizational Excellence (CMQ/OE) is preferred