Sr Director, Quality Assurance - CMC

Role Summary

Sr Director, Quality Assurance - CMC will lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.

Responsibilities

• Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.
• Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.
• Oversee QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and protocols/reports.
• Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs.
• Provide Quality oversight of CDMOs and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers.
• Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance.
• Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up.
• Drive phase-appropriate quality system improvements for development-stage programs.
• Participate in Quality governance forums, providing expert input on GMP requirements and alignment with global Quality strategy.
• Lead and develop a team of QA professionals supporting development programs; provide coaching, feedback, and career growth opportunities.
• Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation.
• Create, maintain, and enhance Standard Operating Procedures governing Development QA activities.
• Support investigations and root cause analysis of product or process issues related to clinical manufacturing.
• Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs.
• Responsible for final product Quality release/rejection and related processes.
• Support supplier and internal audits as necessary.
• Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc
• Additional duties as assigned

Qualifications

• BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
• Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage programs; advanced degree may substitute for years of experience.
• Minimum 7 years of direct GxP experience (GMP, GCP, and/or GLP) in a regulated environment supporting biologics, drug products, or combination products.
• Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development.
• Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and vendor management experience.
• Proven expertise in root cause analysis, investigations, change control, and Quality risk management.
• Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
• Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment.
• Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels.
• Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input.
• Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills.
• Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending/statistical analysis preferred.
• ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred.

Education

• BS degree required; advanced degree strongly preferred.

Additional Requirements

• Travel: 40% domestic and/or international