Associate Director of Quality

Akron Bio is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

The Associate Director of Quality is responsible for leading and managing a team of Quality Assurance professionals. This role oversees critical quality systems including CAPA, document control, product disposition, labeling, managing and leading internal and customer audits, and Quality Review Board (QRB) operations. The Associate Director also provides strategic QA support across manufacturing and testing operations, ensuring compliance with regulatory and industry standards while driving continuous improvement initiatives.

Responsibilities

• Lead, mentor, and manage a team of QA professionals to ensure departmental and organizational objectives are met and operating in accordance with cGMP and ISO standards.
• Oversee and manage Quality Review Board (QRB) activities, Corrective and Preventive Action (CAPA) systems, document review and traceability/release processes, final product disposition, and labeling controls.
• Provide QA expertise in cross-functional troubleshooting, root cause analysis, and problem-solving efforts related to intermediate, drug substance (DS), and drug product (DP) manufacturing and testing.
• Collaborate as the QA functional representative on cross-functional teams, supporting initiatives such as Failure Modes and Effects Analysis (FMEA), risk management, master validation planning, LEAN initiatives, and continuous improvement efforts.
• Partner with Operations to proactively identify and implement best-in-class quality manufacturing practices.
• Design, implement, and manage QA training programs to ensure key personnel are properly trained and compliant with applicable standards.
• Act as administrator for the TrackWise QMS, and interface with other systems such as SAP (inventory management) and BlueMountain (Asset Management)
• Ensure ongoing compliance with applicable Quality System Regulations, current Good Manufacturing Practices (cGMP), and industry standards.
• Develop and manage the internal audit program, ensuring timely execution and effective reporting of findings and improvements.
• Serve as QA lead during internal, client, regulatory, and third-party audits.
• Prepare audit reports, track findings, and ensure timely implementation of corrective actions.
• Conduct compliance audits of contract manufacturers, suppliers, and service providers to ensure ongoing quality and regulatory compliance.
• Author and review high-quality technical documents including SOPs, protocols, reports, and policies, ensuring clarity, accuracy, and regulatory compliance.
  
  

Requirements

• BS in Biology, life science or equivalent preferred; a combination of experience and/or education may be considered.
• At least 10 years working in the biopharmaceutical, cellular therapy, or gene therapy industries.
• Knowledge of FDA, CFR, GMP, ISO-9001, and ISO 13485 regulations and standards.
• Superior interpersonal and team building skills.
• Excellent verbal communication and presentation skills.
• Demonstrated excellence technical writing skills and able to clearly coney ideas in writing.
• Experience with Trackwise QMS.
• Fluent in English
• Shows a high degree of initiative, resourceful, and results oriented.
  
  

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match
• PPO and HMO medical insurance plan availability
• Company paid dental and vision insurance
• Company paid short-and long-term disability
• Company paid life insurance
• Company paid holidays
• Generous paid time off allowances
• Employee referral bonus
• Employee gym reimbursement program
• Employee recognition program
  
  

EOE/DFW