Senior Manager, Quality Control (Small 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.

Key Responsibilities

Quality Control Operations & Product Release

• 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.

Analytical Characterization & Method Lifecycle

• 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.

Compliance, Investigations & Inspection Readiness

• 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).

Regulatory Filings & Lifecycle Support

• 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.

Cross‑Functional & External Collaboration

• 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.

Continuous Improvement & Operational Excellence

• 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.

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

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.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Company 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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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