Work for a company that is making a difference in the fight against cancer. Astex Pharmaceuticals, Inc., www.astx.com, brings together high tech and biotech to discover and develop more effective medicines for the treatment of cancer. We are looking for a motivated, dedicated professional who wants to combine their skills with our uniquely talented team to change the current paradigm of drug discovery and development. This position will be based in the Corporate Office located in Dublin, California, just a 10-minute shuttle ride from the Dublin-Pleasanton BART station.
The Director/Senior Director, Global QA-GCP will lead and be responsible for all QA activities associated with GCP. This role will be an integral part of an experienced team and will ensure the highest quality performance of Astex, our investigators, and related personnel and sites. This is a hands-on position that is also responsible for managing contract staff.
• Responsible for all QA-GCP activities for Astex.
• Provide Quality input to all clinical trial-related activities
• Participate in the review of all regulatory documents and be responsible for their final approval
• Develop and maintain processes and formal procedures to ensure Astex performs to the highest Quality standards.
• Identify risks, and proactively create and implement mitigation strategies
• Manage QA-GCP activities to ensure appropriate information is obtained and communicated
• Provide senior management with the necessary information resulting from GCP audits
• Develop and implement short- and long-term audit plans to ensure Phase 3 readiness, inspection readiness and NDA approval
• Work with team members to develop and implement compliance programs for clinical activities
• Ensure SOPs are reviewed and updated on a regular basis, and ensure staff are trained on their implementation
• Ensure inspection readiness of all activities
• Drive and establish a commitment to quality, professional excellence and appropriate regulatory compliance in all Astex clinical activities
• QA-GCP activities will conform to the company's business strategy, industry standards and compliance with global regulations
• Travel will be required and the extent will be determined by your audit plan
• Minimum education: MS degree. PhD, PharmD or JD is desirable
• Minimum experience: 10 years QA-GCP in a pharmaceutical or biotechnology company with hands-on and managerial activities, with in-house and contract staff
• Experience with IND and NDA submissions
• Prior experience in oncology or hematology is highly desirable
• Familiar and comfortable with clinical concepts, practices and regulations regarding clinical trials
• Familiar with data processing methods, general knowledge of clinical medicine, oncology, and medical terminology
• Exceptional communication and organizational skills
• Ability to perform all GCP activities with minimal guidance
• Forward looking
• Possess strong critical thinking and problem-solving skills
• Ability to manage multiple internal and external activities
Astex Pharmaceuticals is an Equal Opportunity Employer