Associate Director, Investigational Products QA

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe. 

Exciting Opportunity at MSK: Join our team as an Associate Director, Investigational Products Quality Assurance (IPQA)! We are looking for an experienced and dynamic quality assurance professional to lead and administer MSK's centralized IPQA program, providing oversight and guidance to MSK core facilities, pharmacies, and laboratory quality teams. In this role, you be responsible for the quality and regulatory compliance of new and existing MSK investigational products intended for clinical trial programs.  

Role Overview:  

• Conduct QA reviews, inspections, or audits of early-phase non-clinical and clinical product development studies to ensure compliance with regulatory and institutional standards. 

• Support the development, qualification and validation of new MSK facilities for investigational product manufacturing and testing. 

• Oversee and maintain controlled document systems within IPQA, MSK laboratories, and pharmacy facilities, ensuring accuracy and regulatory compliance. 

• Ensure personnel training is completed, documented, and up to date, while   maintaining accurate training records, and ensuring content remains current and relevant. 

• Contribute to the implementation and continuous improvement of quality practices for MSK manufacturing and testing facilities. 

• Provide QA oversight, guidance and consultation for the review of institutional policies, local procedures, quality plans, and quality manuals. 

• Ensure compliance of the MSK Manufacturing Quality System (MQS) and investigational product-related facilities with institutional policies and regulatory agency requirements. 

• Support GMP issue escalation and provide QA review, approval and resolution of GMP-related records and deviations. 

• Communicate critical events, risks and quality issues to Laboratory or Facility Heads, Director, and senior management in a timely manner. 

• Support and lead internal corporate audits and regulatory agency inspections, ensuring readiness and compliance. 

• Identify, analyze and implement quality improvement initiatives based on quality metrics and data analysis. 

• Lead and manage departmental and high-level projects ensuring alignment with organizational objectives and regulatory expectations.  

• Provide leadership, mentorship, and development opportunities to direct reports, fostering a culture of continuous improvement and professional growth.  

Key Qualifications:  

• 8+ years of experience in pharmaceutical, biotech, or clinical research industries, with a strong focus on quality assurance and investigational products. 

• Master’s degree Science, related to medicine or medical product development. 

• Extensive knowledge of GMP, GCP, GDP, ICH guidelines, and regulatory requirements for investigational products. 

• Expertise in quality system compliance, controlled document management, and QA processes related to investigational products. 

• Experience in clinical trial materials (CTM) manufacturing, labeling, and distribution. 

• Strong background in internal audits, regulatory inspections, and deviation management. 

• Proven ability to handle GMP-related issues, deviations, CAPA processes, and risk mitigation strategies. 

• Experience in strategic planning, quality improvement initiatives, and program development. 

• Ability to work cross-functionally in a fast-paced, regulated environment, ensuring compliance and operational efficiency. 

• Strong leadership, problem-solving, and team development skills. 

Core Skills:  

• Strong organizational and prioritization skills to manage multiple projects effectively. 

• High attention to detail and accuracy in documentation and compliance activities. 

• Outstanding communication and interpersonal skills, with the ability to engage confidently at all levels. 

• Ability to apply logical, systematic, and creative problem-solving approaches. 

• Commitment to MSK’s vision, mission, and values, demonstrating enthusiasm and dedication. 

Additional Information:  

• Location: 633 Third Avenue, NYC 

• Schedule: Monday - Friday, hybrid 

• Reporting to: Sr. Director, Clinical Research QA 

Pay Range:  $134,600.00-$222,200.00

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Helpful Links:  

• MSK Compensation Philosophy 

• Review Our Greats Benefits Offerings 

MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.  

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.