Quality Manager (Gene Therapy, Operational and Audit QA) (v100)

Lenox Executive Search is seeking to fill a contractual role for a Quality Manger with one of our global pharmaceutical clients. This is a one-year contract role that can be REMOTE.

General Quality Manager summary:

The Quality Manager will be supporting the activation of commercial gene therapy Authorized Treatment Centers.

The successful applicant will perform quality risk assessments and assist with completion of quality agreements, provide operational support for commercial site selection and activation of apheresis and cell-therapy laboratory centers. This role will be supporting the activation of the Authorized Treatment Centers (commercial sites) and will work closely with the Apheresis and Infusion Operations team and the QA Audit team in qualifying sites partnering to provide life saving cell and gene therapy to patients in need.

The Quality Manager will complete the execution of the quality Risk Management Plans that will govern the monitoring and oversight by QA and business functions, working closely with the business stakeholders and the functions within the Quality organization with the objective of ensuring transparency for gaining insights regarding operational risks and mitigations.

The Quality Manager is responsible to support real time treatment center assessment activities within VCGT Quality. The Quality Manager will utilize their technical expertise to optimize interdisciplinary understanding and synergy with the group and integrate activities with other departments to shape a cohesive environment.

This role will be remote or hybrid, but with travel and some office presence and responsibilities necessary.

Key Responsibilities of a Quality Manager:

The position is responsible to ensure the successful execution, but is not limited to the following:

• Work closely with the Audit and Inspection quality function to establish the audit strategy for Auditing and Performance oversight to evaluate treatment centers ensuring compliance with standards established by applicable regulatory, licensing, and accrediting bodies
• Conduct treatment center Audits where required
• Actively engage with the Audit Management, Vender Management and Apheresis Infusion Operations functions on site qualifications
• Establish and maintain Quality Agreements
• Work with the business areas on site selection
• Provide QA support of change controls, investigations, CAPA’s and effectiveness checks
• Responsible for identifying risks and communicating gaps for process/systems
• Coordinate preparation activities with SMEs

Real-time Inspection Readiness

• Develop, utilize, and continue to mature tools to ensure efficiency in execution
• Support initiatives associated maintaining relevant inspection related history for inspection readiness purposes

Other Activities

• Identify areas of improvement and participate in process improvement initiatives
• Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement
• Additional activities as needed to support the Quality Systems
• Author/Revise Standard Operating Procedures and associated forms.

Minimum qualifications of a Quality Manager:

• Bachelor’s degree required
• Master’s degree and 0 – 3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 3+ years of relevant work experience, or relevant comparable background
• Quality Assurance experience supporting apheresis, transplant, or cell-therapy lab in a biotech/pharma or healthcare setting

Preferred Qualifications of a Quality Manager:

• Strong apheresis and/or cellular therapy Quality or Operations background
• Project Management Skills
• Operational QA experience with experience with the following is preferred:
• Inspection support roles
• Quality System background
• Understanding of GMP/GDPs and applicable guidelines/guidance
• Ability to collaborate with cross-functional teams
• Excellent technical writing, presentation, and communication skills
• Experience conducting investigations, performing Root Cause Analysis, and identifying CAPA