Associate Director/Director, Quality Assurance, CMC

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

📋 Description

• Ensure quality oversight throughout the development, manufacturing, and regulatory approval processes for Dianthus products.

• Direct QA supervision of external manufacturing organizations (CMOs) and testing entities (CTOs) related to biologics and combination products.

• Evaluate and authorize protocols, master batch records, specifications, analytical test methods, raw data, stability reports, and method qualification/validation reports.

• Ensure that clinical manufacturing activities comply with cGMP standards as well as Dianthus policies and procedures.

• Manage the disposition of cell banks, drug substances, and finished drug products for clinical supplies.

• Collaborate with the external Qualified Person to verify that the investigational product meets release criteria in the EU.

• Supervise the review and approval of labels and artwork.

• Contribute quality insights to process development, technology transfer, comparability assessments, and stability strategies.

• Lead investigations into deviations, out-of-specification (OOS) results, and change controls, including conducting root-cause analyses and assessing product impacts.

• Lead or engage in risk assessments, including design and process FMEAs.

• Develop, implement, and sustain phase-appropriate quality systems.

• Keep abreast of regulatory changes and update quality documentation as necessary.

• Act as a subject matter expert on CMC quality and compliance matters.

• Cultivate strong quality relationships with CMOs, CTOs, and strategic partners.

• Assist in GMP supplier audits and regulatory inspections.

• Support IND, BLA, IDE, and PMA regulatory submissions and oversee QA submission reviews.

• Carry out additional duties as assigned.

⛳️ Requirements

• Bachelor's or Master's degree in Biology, Chemistry, Engineering, or a related life sciences field.

• Over 10 years of experience in the biotech or pharmaceutical sectors focusing on large molecules/biologics, including a minimum of 5 years in Quality Assurance oversight roles.

• 5+ years of experience in developing, managing, and overseeing quality relationships with CMOs.

• 5+ years of experience in batch disposition of GMP materials.

• Background in a pharmaceutical manufacturing setting.

• Comprehensive understanding of cGMP regulations and the drug development lifecycle, including 21 CFR Parts 210 and 211, 600s (for biologics), EU GMP including Annex 1, and ICH Q8, Q9, and Q10.

• Familiarity with aseptic and sterile manufacturing principles.

• Strong knowledge of quality systems, covering deviations, OOS, CAPA, change control, supplier management, and batch disposition.

• Experience in drafting standard operating procedures.

• Proven ability to review analytical test results and related raw data.

• Experience in participating in formal, documented risk assessments like FMEA.

• Demonstrated project management capabilities.

• Ability to comprehend business needs and convert them into practical, phase-appropriate quality solutions.

• Exceptional written and verbal communication skills.

• Preferred: experience with combination products and/or medical devices, including knowledge of 21 CFR Part 4 and 21 CFR Part 820/QMSR/ISO 13485.

• Preferred: at least 2 years of GxP auditing experience.

• Preferred: familiarity with electronic quality management systems like Veeva.

🏝️ Benefits

• Option for remote work.

• Chance to influence investigational medicines provided to patients.

• Collaboration with cross-functional teams and strategic external partners.