Director​/Sr. Director CMC & Quality Assurance

Major Duties and Responsibilities

• Lead/oversee CMC QA quality control business process build-out for drug products (technical operations; qualification/validation and execution of analytical methods; method validations/transfers; material specs; stability data; expiry date extensions; cleaning validations).
• Serve as the CMC representative in health authority and notified-body meetings, inspections, and responses for combination product topics.
• Proactively identify regulatory risks for drug-device configurations (e.g., bridging, platform devices, design control) and drive mitigation.
• Oversee integration of drug, device, and primary container data (engineering, usability, biocompatibility, extractables/leachables, connectivity) into the CMC strategy.
• Ensure compliance with FDA, EMA, GxP, ICH guidelines, Rani procedures, and industry best practices.
• Support internal/external GMP manufacturing and oversee GMP sample handling/testing, QC stability program, QC release/stability data analyses, OOE/OOS investigations, deviations, CAPAs, and certificates of analysis for drug products.
• Ensure QC deliverables are cGMP compliant in a phase-appropriate manner to support clinical and commercial programs.
• Provide GMP quality oversight (approval of method validation, specifications, and release testing for raw materials/intermediates/excipients/APIs/drug products).
• Oversee external contract/vendor analytical labs (method development, qualification, transfer, validation).
• Develop/approve/monitor/maintain critical quality standards and risk-based continued process verification/monitoring across product lifecycle.
• Manage supplier qualification and requalification for CROs and CDMOs.
• Ensure processes are in place for clinical/commercial product and process lifecycle quality (control strategy, technology transfer, process validation lifecycle, quality monitoring).
• Collaborate across analytical development, technical operations, manufacturing, QA, regulatory affairs, clinical development, program management, and external CROs/CDMOs.
• Engage with analytical development to build a sustainable GMP QC platform for a growing clinical/commercial portfolio.
• Support quality review of CMC sections of regulatory filings and inspection readiness.
• Act as CMC subject matter expert for external due diligence, regulatory interactions, and partner engagements.

• PhD in a scientific discipline with 7+ years’ experience OR MS/BS with 10+ years’ experience in Analytical Development/Quality Control in a GxP pharmaceutical environment.
• Track record of implementing phase-appropriate quality control strategies, method validation, and specification development.
• Working knowledge of cGMP (21 CFR 210/211), ICH guidelines, applicable regulatory requirements (FDA/EMA/EU/PIC/S/ISO) and pharmacopeia standards.
• Experience managing analytical development/QC activities at CROs and CDMOs.
• CMC regulatory knowledge; understanding of manufacturing/process development/quality control/QA for biologics and/or combination products.
• Expert knowledge of cGMP compliance for US/EU.
• Combination products experience preferred.
• Proficient in risk assessment and root cause analysis tools.
• Understanding of domestic/internal quality systems regulations; strong continuous improvement mindset.
• Ability to coach/mentor cross-functional teams.
• Strong communication skills and ability to present to broad groups.

• Able to work in a fast-paced, changing environment; manage multiple competing responsibilities with self-motivation.
• Excellent verbal/written/interpersonal/organizational skills; ability to influence across the organization.
• Collaborative, goal-oriented; strategic as well as hands-on.
• Strong attention to detail; independent decision-making.

$230,447 - $275,000 per year