Executive Director, Quality Management and GxP Systems
Executive Director, Quality Management and GxP Systems
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$ 257000 - 314000
1 Vacancy
Job Description
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative firstinclass medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
- Develop maintain and optimize global QMS strategy and processes based on relevant regulatory requirements and aligned with corporate goals
- Provide updates and strategic recommendations to the executive leadership team relating to quality management and GxP oversight and compliance
- Manage and oversee all aspects of GxP QMS functions for clinical and commercial products comprising Document Control and Training; Computer Systems Validation deviation CAPAs and Complaint Handling; Internal QMS Audits and Supplier Quality Management including Quality Technical Agreements
- Monitor emerging regulatory trends and ensure proactive adaptation of processes changes
- Partner with manufacturing analytical development and quality control supply chain regulatory affairs manufacturing and clinical teams to ensure alignment on quality and compliance objectives
- Partner with IT and systems owners to ensure 21 CFR 11/Annex 11/GAMP 5 compliance of the automated equipment and computer systems life cycle
- Identify assess and mitigate GxPrelated risks across the supply chain (end to end) vendors and relevant processes
- Build mentor and lead a highperforming QMS team by fostering a culture of quality accountability and collaboration within the team and across the organization
- Oversee the selection qualification and ongoing monitoring of all GxP vendors
- Ensure partners and vendors compliance with contractual obligations quality agreements and regulatory requirements
- Lead the team that manages all Ardelyx product complaint handling activities
- Ensure robust and compliant processes managing product complaint handling and comprehensive investigation and CAPAs
- Develop and implement policies and SOPs Work Instructions/Forms and training materials as required in support of continuous improvement initiatives
- Develop systems for the analysis and reporting of product and process quality trends and quality system performance against internal and external guidelines standards and regulations
- Lead training curriculum development annual refresher training and conduct gap analysis to identify Ardelyx training opportunities
- Oversee the activities of external Auditors/CSV contractors and/or consultants
- Bachelors degree with 15 years of related experience in pharmaceutical quality systems and GxP Systems or equivalent experience
- 10 years experience in a Quality environment with exhibited knowledge and proficiency of Quality System requirements
- Understanding of CFR Title 21 (Parts 11 210 and 211)
- Understanding and familiarity with FDA regulatory requirements guidelines and recommendations for product complaints
- Extensive experience with Quality Assurance systems and processes
- Excellent leadership technical management problem solving and project management skills
- Excellent communication and organization skills required
- Ability to present data and defend approaches in front of audiences and inspectors
- Experience and proficiency with industry standard enterprise system applications (QMS EDMS)
Required Experience:
Director
Employment Type
Full-Time
