Senior Director of Technical QA (GMP)

On-Site 4 days per week at our Palo Alto, CA, Princeton, NJ or Miami, FL offices

Overview of Role:

The Senior Director QA will report to the Vice President, Quality Assurance and Regulatory CMC, and provide comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for Summit’s oncology pipeline. The Senior Director will serve as the primary quality interface between internal CMC Technical Operations and external manufacturing partners and will play a pivotal role in supporting clinical and commercial readiness milestones.  The Sr. Director will focus on readiness for BLA filing, and PLI readiness. This position requires a seasoned quality leader capable of operating at both strategic and tactical levels, with a track record of driving GMP compliance in the development of biologics.

​Role and Responsibilities:

• Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture.
• Collaborate with MSAT team on process development, technology transfer, scale-up activities, and other manufacturing changes and provide quality oversight and input.
• QA Lead for Process Performance Qualification (PPQ/PV), Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), and Computer System Validation (CSV) activities.
• Lead and ensure GMP inspection readiness activities for Summit and external CMOs and manage all regulatory inspections in collaboration with relevant stakeholders
• Mentoring other individuals within the organization in the area of compliance.
• Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions as appropriate
• Serve as the primary GMP quality lead for CMC regulatory submissions, including IND, IMPD, BLA/MAA modules and ensure all CMC documentation are accurate.
• Supervise and guide internal audits of departments and processes
• Review existing policies and procedures, and develop new and enhanced policies that ensure compliance to regulations
• Write, revise, review and/or approve SOPs, controlled documents to ensure compliance with all applicable regulations
• Drive cross-functional collaboration and alignment with other departments, and stakeholders to achieve quality and compliance objectives
• Develops a robust quality system and fosters best practices across the organization
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met.
• Establish and maintain performance metrics

 Experience, Education and Specialized Knowledge and Skills

• Bachelor’s degree in chemistry, biochemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific disciplines.  Higher degree (MS, PhD, PharmD) strongly preferred
• A minimum of 15 years’ experience in the pharmaceutical industry with at least 8 years' experience in commercial manufacturing of drug substance and drug product.
• Biologics experience is essential. Working knowledge in analytical laboratory testing is a plus.
• Experience in the use of e-QMS to effectively execute quality systems such as MasterControl or TrackWise. Strong proficiency in CMC regulatory submissions, with direct experience reviewing IND/IMPD sections, BLA/MAA CMC modules.Strong expertise and experience with GMP manufacturing requirements for clinical and commercial biologics
• Demonstrated ability working with and managing CMOs
• Experience in designing and implementing quality systems and risk management tools
• Experience leading/hosting US and international health authority inspections
• Excellent communication skills both oral and written.
• Experience in working independently on multiple programs in a fast-paced environment with and able to balance changing priorities
• Attention to detail, self-motivated with a strong sense of work ethic
• Excellent interpersonal skills and collaborative