Director, Quality Control

Primary Responsibilities

• Defines and executes the strategic vision for the Quality Control function to support clinical and commercial programs
• Establishes organizational structure, capabilities, and processes to support growth and future commercialization
• Participates in Pharmaceutical Quality leadership team activities, contributing to functional goals, priorities, and budgets
• Leads and develops QC personnel, including oversight of training, performance, and team development
• Oversees external QC laboratories, including testing execution, data analysis, and issuance of Certificates of Analysis
• Defines, tracks, and trends laboratory performance metrics (e.g., quality, capacity, turnaround time, non-conformances) to drive partner accountability and continuous improvement
• Leads analytical troubleshooting efforts in collaboration with contract laboratories
• Ensures alignment of external partners with program timelines to enable product disposition
• Reviews and approves analytical method qualification and validation protocols and reports
• Authors, reviews, and approves stability protocols and reports and supports assignment of product expiry
• Supports establishment of critical quality attributes (CQAs) and product specifications for Drug Substance (DS) and Drug Product (DP)
• Pairs with QA to ensure effective oversight of cGMP QC activities, including change control, deviations, investigations, CAPAs, and batch disposition support
• Leads Out of Specification (OOS) and Out of Trend (OOT) investigations
• Authors, reviews, and approves QC standard operating procedures
• Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities
• Participates in regulatory inspections and ensures inspection readiness across QC activities
• Collaborates closely with Quality Assurance, Manufacturing, CMC, Supply Chain, Regulatory Affairs, and Project Management to align quality and program objectives
• Oversees stability and reference standard programs to ensure compliance with regulatory expectations

Education and Skills Requirements

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline; advanced degree (PhD) in Chemistry or Analytical Chemistry strongly preferred
• 12+ years of experience in Analytical Development and/or Quality Control within a GMP-regulated environment
• Strong expertise in analytical techniques (e.g., SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA)
• Deep knowledge of cGMP regulations and global guidance (FDA, ICH, EU)
• Experience with compendial and product-specific analytical methods for biologics and/or small molecules
• Demonstrated experience managing external QC laboratories and vendor performance
• Experience supporting CMC regulatory submissions from IND through BLA and commercialization
• Experience with oligonucleotide therapeutics, mass spectrometry, or bioanalytical assays is a plus
• Proven leadership experience, including building and developing teams and driving organizational effectiveness
• Strong strategic thinking and problem-solving capabilities with the ability to translate strategy into execution
• Excellent interpersonal, communication, and negotiation skills with the ability to influence internal and external stakeholders
• Highly collaborative leader who fosters cross-functional alignment and drives results in a fast-paced environment