Associate Director, Quality Assurance, GCP

Summary

Join Erasca, a clinical-stage precision oncology company, as a part-time Quality Assurance professional. You will be responsible for overseeing vendor audit policies, quality system elements, and GxP audit activities supporting clinical programs. The role also involves facilitating quality contractual reviews, overseeing supplier performance, and supporting GDPR compliance. This position requires collaboration with cross-functional stakeholders in clinical operations and development. The position is a part-time contract (20 hours/week) and can be based anywhere in the US. Erasca offers a comprehensive benefits package.

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
• 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

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

Preferred Qualifications

• 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

Benefits

• Paid Time Off
• Holiday and Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, and Commute)
• Critical Illness and Accident Coverage
• Pet Insurance
• Employee Assistance Program
• 401(k) Plan with Erasca contribution
• The opportunity to participate in an Employee Stock Purchase Program