Senior Manager, Quality Control; Molecules

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.

• 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.

• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline (required).
• Master’s degree or PhD preferred.

• 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.
• Experience with DS and DP release testing, analytical characterization, and QC support of regulatory filings.

• 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.

Accountability for Results: Stay focused on key strategic objectives, be accountable for high standards of…