Associate Director of Quality
- 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.
- 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.
- 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
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