Senior Director, Quality Control

Key Position Responsibilities

• Envision and drive Solid’s QC strategy, including the implementation of policies, structures, and methodologies to support late-stage clinical programs
• Lead and oversee QC activities at CDMOs and external testing labs, ensuring the timely execution of release tests to facilitate batch disposition under accelerated timelines
• Lead and develop a team of experienced QC professionals
• Provide QC leadership and support with regulatory submissions (IND/BLA)
• Review SOPs, protocols, reports, impact assessments and root cause analyses
• Oversee laboratory investigations, deviations, change controls, CAPAs, and risk assessments and drive them to successful and timely conclusions
• Oversee the creation of appropriate specifications for excipients, drug substances, and drug products
• Accountable for the continuous improvement of QC systems, such as product specifications, product shelf-life/expiry, reference standard program, stability program, etc.
• Work closely with Analytical Development and Analytical Science & Technology teams to co-lead method transfer, qualification and validation

Experience Requirements

• BS/MS with 15+ years of relevant industrial QC experience with a degree in Biology, Chemistry, Chemical/Biochemical Engineering, or related scientific discipline
• 7+ years of demonstrated people leadership experience within the QC function
• Extensive experience managing CDMOs and Contract Test Labs activities
• Experience authoring and reviewing CMC sections of Regulatory Filings
• Excellent communication skills and ability to build key networks and business relationships across all levels of the business
• Hands-on experience working in a QC lab environment with expert knowledge of both international (e.g. ICH, EU) and national (FDA) quality regulations and guidelines (USP/EP) related to product testing, analytical and stability requirements, validation of analytical methods