Quality Manager (REMOTE)
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Location: Remote*CO and NYC candidate may not be considered
target pay: 65-71/hr - varies on years of experience
GENERAL POSITION 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.
This individual is expected to demonstrate success in engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and Quality.
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 position reports to the Associate Director, ATC Operational Quality.
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
o Develop, utilize, and continue to mature tools to ensure efficiency in execution
o Support initiatives associated maintaining relevant inspection related history for inspection readiness purposes
· 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.
· 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
· Strong apheresis and/or cellular therapy Quality or Operations background
· Project Management Skills
· Operational QA experience with experience with the following is preferred:
o Inspection support roles
o 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
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