Ardelyx
Director, GCP Quality Management
TLDR
Lead and modernize GCP, GLP, and GVP audit programs, ensuring a risk-based approach to quality oversight and compliance while fostering continuous improvement across the organization.
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class 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.
Position Summary:
The Director, R&D Quality Management provides leadership for the company’s GCP, GLP, and GVP audit and vendor management programs, ensuring a risk-based approach that strengthens oversight and anticipates emerging quality risks. The role is responsible for GCP, GLP, GVP inspection readiness and drives modernization of quality processes and technology. Working cross-functionally, the Director monitors regulatory changes, and leverages quality analytics to inform decision-making and long-range planning. Through proactive quality-risk monitoring and cross-functional collaboration, the Director enables strong, data-driven decision making and fosters a culture of continuous improvement.
Responsibilities:
- Design and implement a risk-based GCP, GLP, GVP audit strategy that strengthens organizational oversight, anticipates quality risks, and aligns with long-term business development priorities
- Oversee and manage the on-time execution of all audit types (vendor/supplier, clinical investigator site, internal process), including management of contract auditors, corrective action process, and collaboration with internal GxP functions
- Establish proactive quality risk monitoring and mitigation frameworks, leveraging audit outcomes, CAPA trends, and cross-functional signals to drive strategic decisions and enable a culture of continuous improvement
- Define a comprehensive vendor compliance strategy, ensuring external partners are aligned with the company’s quality standards, risk posture, and long-term operational objectives
- Identify and drive opportunities for modernizing quality processes, digital tools, and ways of working and advance nimble, risk-based, data-driven quality operations
- Drive an inspection readiness program that equips the organization to quickly mobilize and effectively engage with global health authorities, including serving in key inspection roles supporting the functional team during inspections
- Partner with clinical development to embed RBQM principles and technologies into operational models, ensuring quality is built into development strategies from design to execution
- Provide quality support and guidance to functional teams, including providing training on relevant quality topics
- Develop, review, and approve procedural documents ensuring they reflect current regulatory expectations, operational realities, and a risk-based approach to quality
- Oversee the use of quality data to identify GCP, GLP, GVP quality trends, inform Quality Management Review, and influence strategic planning across R&D and QA
- Monitor changes in the regulatory landscape and assess their implications for the business to drive modern quality and compliance strategies
- Manage and/or coach internal staff and consultants, cultivating a team capable of advancing modern quality practices and delivering high-quality, on-time results
- Perform other related duties and support continuous improvement projects as assigned
Please note: this position is hybrid based out of our Waltham, MA office and requires a presence on-site 2-3 days per week.
Qualifications:
- Bachelor’s degree in scientific, legal, or other applicable discipline, with 10+ years in the pharmaceutical industry, with exposure to multiple regulated areas, or equivalent experience
- Direct experience auditing and overseeing GCP compliance
- Experience in GLP and/or GVP quality is strongly desired
- Knowledge of GCP compliance activities necessary for clinical trial management and study site management
- Demonstrated experience in leading, managing and improving pharmaceutical quality systems
- Experience with RBQM and Quality by design
- Experience working with and overseeing external service providers
- Hands-on experience participating in regulatory inspections
- Demonstrated experience in managing pharmaceutical quality systems such as Management Review, Document Management, Training, Deviation/Investigation, CAPA, and Quality Metrics reporting
- General understanding of pharmaceutical research and development; ability to partner with the business functions to enable high quality outcomes
- Experience using Veeva Quality Management systems is strongly desired
- Strong leadership, technical, management, problem solving and project management skills
- Good presentation, verbal and written communication skills
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Benefits
Health Insurance
Health plans (medical, prescription drug, dental, and vision)
Other Benefit
Annual Winter Holiday shut down
Paid Parental Leave
12 weeks of paid parental leave
Paid Time Off
At least 11 paid holidays
Ardelyx is a biopharmaceutical company focused on developing and commercializing first-in-class medicines aimed at significant unmet medical needs. With products like IBSRELA® and XPHOZAH®, Ardelyx utilizes innovative solutions to address critical health issues such as IBS and hyperphosphatemia, both in the U.S. and through partnerships in international markets.