Currentjob openings

Position Summary:   

This position will be responsible for the execution and oversight of vendor audit policies, plans, and quality system elements related to GxP audit activities in support of clinical programs & studies along with external GxP qualifications and inspection readiness. In addition, the role facilitates quality contractual reviews and obligations (such as Quality Agreements), oversees supplier scorecards, performance and quality, and supports GDPR compliance and serious breach assessment. This person will sit on clinical study teams and work closely with cross-functional stakeholders in clinical operations, clinical development, data management, and other functions involved in the conduct of Erasca clinical trials. 

Note this is a part time contract position, 20 hours per week, and can be based anywhere in the United States. 

Responsibilities:  

• Establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in international regulatory environment and provide guidance in clinical Quality related areas.
• Represent Quality Assurance on cross-functional study teams.
• Support GCP QA in the conduct and oversight of GxP vendor audits (GMP, GCP, GLP, and & GVP), including IT systems.   
• Maintain risk based GxP supplier/vendor audit schedule and performance overview in compliance with procedures. Author (or ensure authorship for outsourced audits), review, and approve internal and external audit reports.  
• Review audit findings and other potential compliance risks to subject safety, data integrity, and business operations and escalate risks to QA management.  
• Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures as well as ensuring appropriate effectiveness checks through subsequent vendor audits. 
• Author, review, and facilitate contractual agreements (Quality Agreements, Pharmacovigilance Agreements (PVA), etc.).
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Requirements:  

• Undergraduate degree in in Biology, Chemistry, Physical Sciences, or related discipline, or comparable experience. 
• 10 years of experience including management of GxP Quality/Compliance audits in a pharmaceutical or biotech environment required.
• Extensive knowledge of ICH Guidelines, US, European, and ROW regulatory requirements regarding applicable drug development regulations.  
• Experience with transition from Phase 1-3 to commercial quality systems preferred. 
• Previous experience working with FDA and participating in regulatory agency inspections of clinical research activities.
• Excellent interpersonal and influencing skills.
• Must have good written and verbal communication skills with the ability to tailor communication to all levels and prepare and present appropriate updates to functional groups and leaders. 
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Strong learning orientation, curiosity, and commitment to science and patients.