The Director of Quality Assurance with be part of the non-clinical development team and reports to the CSO. This position will work with the CMC team executing late-stage development in support of Phase III clinical trials and NDA readiness activities. This role is independently responsible for the development, implementation and management of Eidos’s quality systems and operations ensuring compliance with GMP, GLP, and other relevant regulations for R&D and commercial production activities.
• Establishes procedures and specifications affecting product quality and oversees the development of batch records, SOPs, and validation protocols
• Interacts with manufacturing, clinical, operations or other functional areas as they impact quality operations and ensures cross-functional completion of issues or actions identified
• Collaborate with internal stakeholders to implement and oversee company GMP training program.
• Implement electronic document control system
• Implement a QMS in support of late stage development and NDA submission readiness
• Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities
• Performs internal and external vendor audits to assure adherence to company SOPs and regulatory requirements, prepares written reports and follow-up to resolve findings
• Performs external site qualification activities, as well as continual quality oversight (e.g. audits) of external vendors.
• Directs continuous improvement initiatives to accomplish compliance, productivity, cost effectiveness and enhanced efficiencies of processes and procedures as they pertain to quality
• Leads internal audit program focused on prevention versus correction
• Leads the site inspection readiness program
• Is the primary contact with the FDA and supports FDA inspections at Eidos production sites.
• Prompt communication to management of critical and/or compliance issues.
• Bachelor’s degree (advanced/graduate degree preferred)
• Documented training and/or certification in relevant quality fields (e.g. ASQ) a plus
• At least 12 years of progressively responsible experience in Quality Assurance within the pharmaceutical industry
• Previous experience with FDA inspections and interaction with FDA
• Experience in small molecule drug substance and solid oral dose production and development. Commercial launch experience a plus.
• Demonstrated track record in effectively managing and implementing GMP compliant quality systems
• Expert knowledge of GMP regulations
• Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals
• Excellent verbal and written communication skills
• Ability to think critically and takes collaborative approach to problem solving
• Ability to work effectively in regulated and fast paced environment
• Demonstrates high level of professional integrity and trustworthiness with strong work ethics
• Position requires 10-20% travel. Must have the ability to travel internationally.
Local candidates only. Relocation packages not offered.
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