Director, CMC Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide oversight and guidance on quality to vendors to guarantee that drug substances, drug products, and finished products are produced, tested, released, and distributed in accordance with cGMP regulations.

• Ensure that CMO and partner manufacturing operations adhere to regulatory standards and Pulmovant's quality expectations.

• Lead the review of batch records and clinical lot disposition.

• Assist in QP certification and governance activities with contract manufacturing partners for ex-US clinical trials.

• Supervise GMP Quality Systems activities at external partners, including handling of deviations, investigations, cAPAs, change controls, and OOS/OOT investigations.

• Conduct and document cGMP audits of vendors, CMOs, contract testing laboratories, contract packaging/labeling, and logistics suppliers.

• Negotiate and uphold Quality Agreements with external partners.

• Offer quality and technical expertise to cross-functional project teams.

• Review protocols, reports, test methodologies, specifications, master batch records, and SOPs.

• Collaborate with CMC, Supply Chain, and Regulatory Affairs to evaluate product quality, identify risks, and formulate mitigation strategies.

• Lead preparation for regulatory inspections and maintain ongoing inspection readiness.

• Support the review of CMC sections in regulatory submissions, including INDs and IMPDs.

• Contribute to responses for health authority inquiries concerning manufacturing and quality.

⛳️ Requirements

• BA/BS degree in Chemistry, Biology, or Life Sciences.

• A minimum of 8 years of experience in the pharmaceutical sector.

• Proven understanding of Quality Systems and cGMP in a regulated environment.

• Demonstrated knowledge of Good Distribution Practices.

• Auditing experience is mandatory.

• Experience in providing quality oversight for CMOs, including conducting audits, batch reviews, and resolving issues.

• Practical knowledge of performance metrics and quality indicators.

• Strong leadership, negotiation, and conflict management abilities.

• Experience in influencing across different functions and organizations.

• Excellent interpersonal skills, including rapport-building, active listening, and effective questioning.

• Proficient in problem-solving and risk-based solutions.

• Exceptional organizational and time management skills with a keen attention to detail.

• Outstanding verbal and written communication capabilities.

• Ability to assess risk and convey recommendations and findings clearly and succinctly.

• Experience in dynamic, start-up environments is preferred.

• Capability to work under pressure, adapt to rapidly changing situations, and meet tight deadlines.

🏝️ Benefits

• Equal employment opportunities and protection against discrimination and harassment.

• Individual contributor role within a streamlined QA team.

• Collaboration and innovation as part of the Roivant family of companies.