Director of Quality Assurance
Clinical Operations | WEST CHESTER, PA | Full Time
ABOUT VERRICA PHARMACEUTICALS
At Verrica Pharmaceuticals Inc., we are passionate about finding solutions to unmet needs in medical Dermatology and are developing therapies for common viral skin diseases. If you want to work in an environment that uses your unique skills and abilities in a fast-paced, small-pharma environment, we’re the team for you.
Director of Quality Assurance will lead the maturation of our quality management systems (QMS) and partnerships with our Contract Manufacturing Vendors (CMOs). Will assure compliance to all applicable regulations and represent Quality Assurance in interdepartmental teams and projects.
The Director of Quality Assurance is responsible for enhancing & maintaining company Quality Systems related to clinical development, production of clinical materials and future commercial manufacturing along with testing. This position will be the overall thought leader for quality at this small but rapidly growing company with a focus on driving quality & regulatory compliance activities for API, drug product and analytical activities.
Specifically, The QA Director is responsible for ensuring that investigational and commercial drug products are manufactured, tested, analyzed, packed, and released for use in clinical trials and/or to market in accordance with industry best practices and respective regulatory requirements and / or registered approvals and in compliance with the principles of cGMP. In addition, position is responsible for over-site of suppliers/contract manufacturing organizations (CMOs) through GMP investigations and audits to ensure regulatory compliance.
The Director of Quality Assurance is required to work at the Verrica Headquarters, located in West Chester, PA
- Support the development and implementation of the Quality Management System related to document development, review and approval as applicable to ensure compliance is achieved and maintained (i.e. SOPs, complaints, deviations, investigations) with focus on drug product and analytical activities.
- Perform thorough batch record review and release in an efficient and timely manner; assure non-conformances are properly investigated and explained, and calculations are correct. Review finished product packs and batch documentation and check against registered specifications prior to market release or advising rejection of batch. Ensure company release documentation for each batch is accurate and filed post release according to procedures.
- Lead the processing and management of change controls.
- Perform root cause analysis of OOS/out of specification issues identified during audits, closure of change controls, corrective actions/preventative actions/CAPAs and leading effectiveness checks.
- Review drug product regulatory dossiers for conformance to source documents. Assess and support GMP compliance for analytical topics (validation and transfer of analytical methods, setting of analytical specifications for the product filing(s)) to maintain compliance with the principle of GMP as required by regulatory filings as well regional or national laws and guidelines. This includes:
- Review and approve protocols, reports, test methods and specifications.
- Conduct, review and/or approve laboratory documentations including deviations/investigations, OOS, and change controls.
- Verify analyses of experimental and stability samples are coordinated and conducted in accordance with cGMPs, company SOPs, methods and protocols.
- Represent Quality Assurance in cross-functional clinical development program teams
- Manage interdepartmental Quality matters and provide Quality related guidance to other departments.
- Lead and manage Quality personnel (internal and external)
- Bachelor's degree or higher degree
- Practical experience for at least 10 years of biopharmaceutical industry experience in a Quality role and a minimum of 5 years of experience in a Quality leadership role; equivalent combination of advanced degree and less experience will be considered
- Good working knowledge of FDA & EU (EMA, MHRA) regulations & cGMPs for a variety of dosage forms and including solid oral and topical, combination products or medical devices.
- Good working knowledge in the analytical space. Good understanding of analytical method validation, pharmaceutical drug substance/drug product analytical technique and microbiological testing requirements.
- Experience working with contractors and with managing Quality technical agreements / QTAs, conducting CMO vendor GMP site audits, etc.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided
- Experience with drug-device combination products is a plus.
- Excellent interpersonal, communication, writing, technical and problem-solving skills.
- Strong analytical knowledge and experience
- Committed to Verrica’s vision, mission, core values and culture.
- Must be able to sit for extended periods of time at a desk.
- Normal requirements for office operations with respect to lifting, standing and walking.
- The position is based at Verrica Headquarters in West Chester, PA
- The position will require travel, sometimes frequent, during routine responsibilities