Pharmacyclics, an AbbVie Company, based in Sunnyvale, CA represents the single largest acquisition AbbVie has ever made, and is key to AbbVie’s corporate strategy to add another very significant growth platform and diversification. Pharmacyclics will be run as a semi-autonomous, fully integrated operating unit of AbbVie, with all functions including among others Commercial, R&D and Manufacturing. The integration into AbbVie should be minimally disruptive for Pharmacyclics; hence the identity, structures and relative independence will be minimally adapted at this time. The new President of Pharmacyclics is Erik von Borcke, currently a senior executive with AbbVie who has relocated to the Sunnyvale Area and reports to the Chairman and CEO of AbbVie, Rick Gonzalez.
General Position Summary:
The Senior Clinical QA Specialist supports the Clinical Quality Assurance (CQA) management in developing its clinical quality systems/procedures and ensuring quality oversight. Activities will cover all aspects of clinical studies and will require a focus on Good Clinical Practice (GCP) , Good Laboratory Practice (GLP), Pharmacovigilance (PV) regulations and guidances.
Key Accountabilities/Core Job Responsibilities:
• Contribute to strategic Clinical QA planning and risk assessment
• Develop CQA plans and implements the actions necessary to ensure clinical trials are conducted in accordance with the audit plan, GCP guidelines and regulatory requirements
• Lead and co-audit US and international sites, internal/external systems and vendors
• Ensure all audits are followed-up and corrective actions are completed, implemented, and verified
• Conduct investigations of GCP-related issues (i.e., product complaints) and develop corrective action plans
• Manage CQA quality systems and support department infrastructure development; assist with creation/revision of appropriate CQA SOPs
• Provide GCP guidance to internal departments for all phases of clinical drug development
• Promote/advance quality awareness throughout the organization; coordinate and provide GCP training
• Work in collaboration with clinical sites, Clinical Operations, Regulatory Affairs and other stakeholders to ensure compliance with GCPs and to maintain inspection readiness
• Review regulatory submission documents (Clinical Study Report and Integrated Safety/Efficacy Summaries) and other essential documents (Protocol, Informed Consent Form, and Trial Master Files)
• Develop metric reports for CQA management of all issues related to the outcome of the audits
• Participate and represent CQA in clinical team meetings and discussions as needed