The Director Pharmacovigilance Quality Assurance is a senior member of the CQA team. The Director will lead and perform day-to-day quality operations and compliance activities to support the success of the drug safety and pharmacovigilance (DSPV) processes, systems, training and compliance programs for both development and marketed products.

Responsibilities:

• Lead Clinical Quality Assurance activities and work with DSPV team to support success of the DSPV processes, systems, training and compliance programs for both development and marketed products
• Champion and influence management and growth of the Clinical Quality Assurance team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s future needs
• Serve as a QA representative and support DSPV team’s procedures and processes to provide compliance advice and strategy that is in accordance with world-wide regulatory requirements
• Provide strategic and compliance advice; participate in the review and approval of required DSPV documents
• Oversee the pharmacovigilance quality management system (QMS), ensuring compliance with global regulatory requirements (e.g., FDA, EMA, ICH, GxP)
• Work with Drug Safety and Pharmacovigilance, IT and other departments to ensure that the safety database is appropriately validated and maintained in compliance with regulatory requirements (e.g., 21 CFR Part 11)
• Perform ongoing gap assessment of the DSPV QMS and feed into the audit plan
• Develop, manage and implement DSPV Audit Plan using risk-based approach for DSPV activities. Conduct audits as necessary of DSPV process, documentation and service providers
• Set inspection readiness strategy for DSPV. Manage and support inspection readiness activities for DSPV
• Manage DSPV related inspections conducted by regulatory agencies, including sponsor inspections, post-marketing Adverse Drug Experience (PADE) inspections, and contract research organization (CRO) inspections
• Oversee the preparation and response to regulatory audits and inspections, ensuring readiness and adherence to regulatory requirements
• Oversee the development of training programs for pharmacovigilance staff to ensure awareness and adherence to quality standards
• Conduct and/or manage qualification of DSPV service providers
• Lead and/or support DSPV non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checks
• Lead metric analyses for DSPV including development and management of KPIs and KQIs for determining the effectiveness of the overall DSPV QMS
• Maintain knowledge of agency and industry trends, standards, and methodologies related to GVPs and notify changes to the applicable teams including possible training
• Provide cross training development opportunities; mentor and coach junior QA team members
• Travel required
• This headquarters-based role requires on-site attendance three days a week

Preferred Skills, Qualifications and Technical Proficiencies:

• Experience in audit and inspection management, with a track record of successful regulatory audits
• Exceptional communication skills, with the ability to interact with senior leadership and external stakeholders
• Ability to perform GVP audits is required
• Experience in developing GVP SOPs and training personnel regarding those SOPs and the government regulations to which they respond
• Thorough understanding of the quality systems that support internal GVP activities for documentation of development and commercial products
• Advanced Microsoft application skills (Word, Excel, PowerPoint)
• Experience in developing GVP processes for the best industry practices and training personnel

Preferred Education and Experience:

• BA/BS degree in biological sciences, pharmacy, related field, or equivalent experience
• 10+ years of experience in pharmacovigilance, including at least 5 years in a leadership or management role including experience in development and maintenance of pharmacovigilance quality systems and performing pharmacovigilance audits for clinical and commercial stage pharmaceutical companies
• Hands-on experience with safety database systems, including validation, audits, and compliance assessments
• In-depth knowledge of global pharmacovigilance regulations, guidelines (e.g., ICH, GVP, other GxP), and safety reporting requirements is required

The pay range that the Company reasonably expects to pay for this headquarters-based position is $218,400 - $256,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.