Senior Manager, Quality Control (Small Molecules)
About the role
The Senior Manager, Quality Control (Small Molecules) will execute and support the strategic and operational leadership for Quality Control activities supporting small-molecule GMP manufacturing, product release, and regulatory compliance. This role is responsible for overseeing QC laboratory operations, drug substance and drug product release, analytical characterization, and regulatory readiness while ensuring robust data integrity, inspection readiness, and continuous improvement across the product lifecycle.
Responsibilities
Manage day-to-day QC laboratory functions supporting small-molecule drug substance (DS) and drug product (DP) release, including raw materials, in-process testing, stability, and finished product testing. Supports QC batch disposition and release testing, ensuring alignment with approved specifications and regulatory filings.
Ensure execution of analytical testing in compliance with cGMP, ICH Q2/Q6/Q7/Q10, USP/EP/JP, and internal SOPs. Review and analyze QC data (release, stability), and lifecycle metrics to support decision-making and identify trends.
Provide scientific leadership for small-molecule analytical characterization, including impurity profiling, degradants, residual solvents, elemental impurities, and solid-state characterization (e.g., polymorphism). Oversee analytical method transfer, validation, verification, and lifecycle management for DS and DP methods. Partner with Analytical Development and external laboratories to ensure methods are phase-appropriate, robust, and filing-ready.
Maintain continuous inspection readiness and support regulatory inspecting during FDA, EMA, and global authority inspections. Review and approve QC deviations, OOS/OOT investigations, CAPAs, and change controls related to analytical methods, specifications, and laboratory systems. Ensure compliance with data integrity (ALCOA+) principles across all QC activities and systems (e.g., LIMS).
Support IND, NDA, ANDA, and post-approval submissions through preparation, review, and approval of QC sections and analytical data. Contribute to preparation of QC-related regulatory documentation and responses for Module 3 (Quality) content related to specifications, analytical methods, validation summaries, and stability. Support regulatory interactions by providing responses to information requests and inspection observations related to QC and analytical control strategy.
Partner closely with Manufacturing, QA, CMC, Regulatory Affairs, and Supply Chain to support clinical and commercial supply. Manage and oversee external testing laboratories, CROs, and contract manufacturing/testing partners. Support technology transfers, scale-up, and site expansions for small-molecule products.
Support continuous improvement initiatives to enhance efficiency, automation, and digitalization initiatives. Implement continuous improvement practices (Lean, Six Sigma) to improve cycle time, compliance, and cost efficiency.
Qualifications
Education: Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline (required). Master’s degree or PhD preferred.
Experience: 10+ years of experience in Quality Control or Analytical functions within small-molecule pharmaceutical manufacturing. 5+ years of people management experience, including leading managers and technical teams.
Technical & Regulatory Expertise: Strong understanding of small-molecule analytical techniques (e.g., HPLC, GC, LC-MS, FTIR, UV, dissolution). Demonstrated experience supporting IND/NDA/ANDA filings and regulatory inspections. Deep knowledge of OOS/OOT management, CAPA, change control, and data integrity expectations.
Benefits
Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.