A growing pharmaceutical company is actively hiring a clinical director of quality assurance full time in San Francisco, CA. If you are looking to work with a dynamic organization on the forefront of innovation within pharmaceutical quality assurance, keep reading!
The Director, Clinical QA is responsible for overseeing the quality strategy, risk management/mitigation, quality systems development/implementation and training activities in support of corporate clinical development objectives. The incumbent will ensure phase appropriate quality standards are established that are in compliance with applicable cGCP regulatory requirements and guidelines; will advise clinical teams and management of any significant quality/compliance risks to development programs in a timely, clear manner. The incumbent represents quality in clinical team meetings, liaises with clinical operations, study managers and biometrics to identify proactive quality systems, training programs and trending tools are enabled to ensure robust processes for oversight and execution of high quality clinical trials. He/She will provide project teams and customers quality/compliance guidance as needed; will triage with Regulatory Compliance and customers to ensure audits are coordinated in a timely manner; will provide Regulatory Compliance audit support as needed; and provide management updates/reports as needed.
Duties and Responsibilities
Responsible for establishing QA policies, procedures and systems to support clinical development activities in compliance to company quality standards and cGCP requirements. Responsibilities include:
Represent QA in clinical sub-team meetings
Partner with Clinical Operations to identify process improvements (best practices) and new technologies for building quality into the scientific and operational design/conduct of clinical trials
Identify and prioritize quality and compliance risks and mitigation plans
Develop and implement written quality management plans to support all Clinical development activities for corporate projects
Review scientific protocols, technical reports and other documentation in support of drug development and regulatory submissions
Work with Regulatory Compliance to ensure audits of CRO’s, specialty service providers (i.e., EDC, e-diaries, IVRS, etc.), data base audits, clinical sites and regulatory documents are performed in accordance to project team timelines. Support Regulatory Compliance as needed and assist with regulatory inspection readiness activities as required.
Defines the standards for QA audits of clinical and regulatory documents (i.e., protocols, IBs, CSRs, IND filings, etc)
Prepares budgets in support of clinical development plans that require consultant support.
Maintain current knowledge of regulatory requirements and thorough understanding of inspection trends, designs programs that advance proactive quality management systems designed to meet or exceed regulatory requirements in a cost effective manner.
Provide GCP training sessions for internal and contract personnel in support of clinical development objectives.
Other as directed by Quality/Regulatory Management
Qualifications
B.S. or advanced degree in science, nursing or related health sciences discipline with a minimum 10 years experience in the pharmaceutical / biopharmaceutical Quality with 7 years direct experience managing Clinical Quality Assurance.
Strong working knowledge and interpretation/implementation of FDA regulations, ICH –GCPs, familiarity with worldwide regulatory guidelines, and experience dealing with regulatory authority inspections is a plus
Ability to deal with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple
Proven management skills with ability to lead and mentor others effectively and experience to advocate a quality environment
Ability to work independently, position requires diplomatic, problem solving skills and engaging personality type with the ability to influence others
Strong organizational skills, able to prioritize work, effectively manage multiple projects while maintaining attention to detail and meeting timelines.
Strong verbal, written and interpersonal skills
Experience with developing effective quality systems, writing SOP, process flow diagrams; working knowledge of software applications used in clinical development and familiarity 21CFR Part 11 requirements.
Some travel may be required (avg. 20% or less)
Direct Reports - None at this time
Industry: Biotech/Pharma
Discipline: Quality Assurance
Experience: 8 - 10 Years
Level: Director
Compensation: $207K
Company: Biotech / Pharma Company