Director, GCP Quality Management

Ardelyx

Waltham, MA

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JOB DETAILS

SALARY

$205,000–$250,000 Per Year

JOB TYPE

Full-time

SKILLS

Auditing, Biotech and Pharmaceutical, Business Development, Business Strategy, Clinical Research, Clinical Trial Management, Coaching, Continuous Improvement, Contract Management, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Management, Drug Development, Employee Benefits, GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GxP, Health Plan, Incentive Programs, Insurance, International Health, Leadership, Legal, Medical Products, Monitor Regulations, Prescription Drugs, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Research & Development (R&D), Risk, Risk Management, Strategic Planning, Systems Administration/Management, Technical Leadership, Time Management, Training/Teaching, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Planning

LOCATION

Waltham, MA

POSTED

27 days ago

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 prioritiesOversee 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 functionsEstablish 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 improvementDefine a comprehensive vendor compliance strategy, ensuring external partners are aligned with the company’s quality standards, risk posture, and long-term operational objectivesIdentify and drive opportunities for modernizing quality processes, digital tools, and ways of working and advance nimble, risk-based, data-driven quality operationsDrive 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 inspectionsPartner with clinical development to embed RBQM principles and technologies into operational models, ensuring quality is built into development strategies from design to executionProvide quality support and guidance to functional teams, including providing training on relevant quality topicsDevelop, review, and approve procedural documents ensuring they reflect current regulatory expectations, operational realities, and a risk-based approach to qualityOversee the use of quality data to identify GCP, GLP, GVP quality trends, inform Quality Management Review, and influence strategic planning across R&D and QAMonitor changes in the regulatory landscape and assess their implications for the business to drive modern quality and compliance strategiesManage and/or coach internal staff and consultants, cultivating a team capable of advancing modern quality practices and delivering high-quality, on-time resultsPerform other related duties and support continuous improvement projects as assignedPlease 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 experienceDirect experience auditing and overseeing GCP complianceExperience in GLP and/or GVP quality is strongly desired Knowledge of GCP compliance activities necessary for clinical trial management and study site managementDemonstrated experience in leading, managing and improving pharmaceutical quality systemsExperience with RBQM and Quality by designExperience working with and overseeing external service providersHands-on experience participating in regulatory inspectionsDemonstrated experience in managing pharmaceutical quality systems such as Management Review, Document Management, Training, Deviation/Investigation, CAPA, and Quality Metrics reportingGeneral understanding of pharmaceutical research and development; ability to partner with the business functions to enable high quality outcomesExperience using Veeva Quality Management systems is strongly desiredStrong leadership, technical, management, problem solving and project management skillsGood presentation, verbal and written communication skillsThe anticipated annualized base pay range for this full-time position is $205,000-$250,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. 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.

About the Company

Ardelyx

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