Eidos Therapeutics, Inc.
San Francisco, California
The Vice President, Quality Assurance (QA) will lead the creation, management, and continuous improvement of EIDOS’s quality management system. This role will develop strong relationships, collaborate, and interact with various departments and levels of management at EIDOS to accomplish company objectives. This individual will also collaborate and develop strong relationships and partner with external collaborators to ensure the appropriate processes, systems, and activities are in place to protect the rights, safety, and welfare of study subjects.
- Ensure compliance with domestic and international current good practice quality guidelines and regulations including Good Manufacturing, Clinical, Laboratory, Distribution and Pharmacovigilance Practice
- Ensure that clinical and commercial drug product is manufactured, tested, released, and distributed in accordance with EIDOS’s established specifications, procedures, clinical requirements and appropriate GxP standards
- Determine the strategy and execution for all aspects of audits, using a risk based approach
- Select, develop, manage, and evaluate QA personnel
- Establish the overall inspection strategy and assures inspection planning across EIDOS as well as enables ongoing efforts to maintain a steady state of inspection readiness
- Engage Senior Management to understand risks, enable awareness and highlight audit results
- Provide periodic reports to Senior Management regarding the performance, effectiveness, and strategies for continuous improvement of the QMS
- Prepare, lead, and present annual Management Review to Senior Management
- Bachelor’s degree in a scientific discipline is required. An advanced degree in a scientific discipline is preferred.
- Minimum of 10 years of progressive responsibility in pharmaceutical/biotech GxP-related Quality environments.
- 8+ years direct and indirect management level experience required.
- In-depth working knowledge of the applicable GCP/GLP/GVP regulations and guidelines.
- In-depth working knowledge of non-clinical and clinical research.
- Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers.
- Leadership: Must be able to lead, manage, and build a GxP Quality team in a fast-paced, growing environment.
- Must be able to prioritize work effectively to ensure the team can meet department and corporate timelines.
- Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
- Ability to travel approximately 25% to various meetings including overnight trips. Some international travel may be required.
- Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
- Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
- Leads by example and highly collaborative with the proven ability to work in a cross-functional team.