What are the responsibilities and job description for the Associate Director Quality Assurance position at AGTC?
Mission
The Associate Director Quality Assurance (QA) leads and develop a team of QA Specialists, provides quality oversight of internal and external activities, documentation, and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.
Reporting Relationship
Duties and Responsibilities
Educational Qualifications
Additional Qualifications
Supervisor Responsibilities
The Associate Director Quality Assurance (QA) leads and develop a team of QA Specialists, provides quality oversight of internal and external activities, documentation, and processes to assure compliance with company procedures and FDA regulations and assists with tasks necessary to achieve departmental and company goals.
Reporting Relationship
- The Associate Director Quality Assurance reports directly to the Executive Director of Quality Assurance or designee.
Duties and Responsibilities
- Provide management oversight of GMP manufacturing and in collaboration with GMP manager.
- Assist in the preparation and conducting of mock and regulatory agency inspections and report responses.
- Manage projects related to new quality initiatives or company-wide projects requiring significant QA support.
- Hire, train, develop, motivates and mentor direct reports.
- Develop, implement, and improve quality systems, programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies.
- Collaborate with the development, implementation, and improvement of corporate quality systems that support early, mid, and late phase gene therapy clinical programs
- Increase compliance awareness and promote a culture of quality throughout the company, with a focus on laboratory and manufacturing operations
- Collaborate with multiple functions to perform QA oversight and ensure quality-related activities are executed efficiently
- Write, review, and revise standard operating procedures
- Provide training to laboratory and manufacturing staff on GLP/GMP regulations, best practices, and internal requirements
- Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
- Perform in-phase inspections in support of GLP studies, write inspection reports and prepare QA statements
- Review and approve Certificates of Analysis and/or Certificates of Test as needed
- Assist in providing leadership for vendor identification evaluation and management activities.
- Oversight of internal and external audits of GxP vendors; assist in the resolution of non-conformances, deviations, and investigations.
- Track open observations and Corrective and Preventative Actions (CAPA) to closure.
- Analyze trends and metrics to ensure continuous quality improvements.
- Interface with contract manufacturing/testing organizations and alliance partners to resolve quality-related issues with minimal supervision
- Assist with monthly QA team meeting and weekly metrics.
- Other duties as assigned.
- This job description is subject to change at any time.
Educational Qualifications
- B.S. degree in a scientific discipline
Additional Qualifications
- At least seven (7) years’ QA experience (8-9 preferred) in a GLP/GMP environment, preferably in a biotechnology company
- Experience in supervising, mentoring or coaching others preferred.
- In-depth understanding of GLP and GMP (drugs and biologics) regulations, guidance documents, systems, processes, and procedures
- Great attention to detail
- Strong interpersonal skills
- Strong prioritization, organizational and negotiating skills
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management
- Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines
- Physical demands: (check one)
- sedentary (< 10 lbs.)
- light work (< 20 lbs.)
- medium work (< 50 lbs.)
- heavy work (< 100 lbs.)
- very heavy work (> 100 lbs.)
- Physical activity: (check all that apply)
- repetitive motion
- balancing
- stooping
- lifting
- climbing
- kneeling/crouching
- crawling
- reaching
- standing
- typing/grasping
- walking
- pushing/pulling
- hearing
- Visual acuity: reading, writing, preparing/analyzing data
- Working conditions: indoor office environment and lab area
Supervisor Responsibilities
- This position requires previous supervisory experience.
Salary : $80,600 - $102,000
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