Director – CMC Quality Assurance

Key Responsibilities:

• Acts as the key Quality Assurance CMC lead on program teams.
• Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, clinical storage, and distribution depots, and other service providers used to support the clinical development programs.
• Monitors third-party vendor performance, and oversees logistics of vendors for compliance including FIH and late phase activities.
• Oversees GMP and GLP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
• Review process and method validation protocols and reports.
• Oversees the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports.
• Review and approve specifications affecting product quality.
• Disposition of clinical and commercial batches
• Provide key input towards development of corporate quality policies, systems and procedures.
• Review and approve change controls, deviations, investigations, CAPA, and Product Quality Complaints.
• Interacts with manufacturing, clinical, operations, or other functional areas as they impact quality operations and ensures cross-functional completion of issues or identified actions.
• Assist in updating CMC sections of regulatory and quality documents.
• Organize and manage QA CMC employee training programs, initiate training sessions including specific GxP training, and maintain training records.
• Participate in risk assessment, review and approve reports.
• Participate in hosting regulatory inspections.
• Prompt communication to management of critical and/or compliance issues.

Qualifications:

• Bachelor’s or Master’s degree in a related scientific field with minimum of 8-10 years of relevant experience in the biopharmaceutical/pharmaceutical industry.
• At least 5 years of progressively responsible experience in Quality Assurance within the pharmaceutical industry; prior management or leadership role preferred.
• Previous experience with FDA inspections and interaction with FDA.
• Expert knowledge of GMP regulations; strong knowledge of FDA, and CHMP/EU regulations.
• Demonstrated record in effectively managing and implementing GMP-compliant quality systems.
• Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers.
• Experience in RNA therapeutics and LNP-formulated drugs is highly desirable.
• Builds effective interactions with a broad range of internal and external organizations, teams, and individuals.
• Ability to think critically and take a collaborative approach to problem-solving.
• Excellent verbal and written communication skills.
• Ability to work effectively in a regulated and fast-paced environment.
• Demonstrates an elevated level of professional integrity and trustworthiness with strong work ethics.
• Able to travel domestically and internationally.