Vice President, Analytical Development & Quality Control

Ardelyx

Waltham, MA

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JOB DETAILS

SALARY

$302,000–$370,000 Per Year

JOB TYPE

Full-time

SKILLS

Analysis Skills, Analytical Chemistry, Analytical Development, Analytical Method Validation, Biotech and Pharmaceutical, Current Good Manufacturing Practice (cGMP), Employee Benefits, FDA (Food and Drug Administration), Health Plan, ICH Regulations, Incentive Programs, Insurance, Insurance Regulations, Laboratory Information Management System (LIMS), Materials Analysis, Medical Products, Mentoring, Outsourcing, Performance Analysis, Performance Metrics, Prescription Drugs, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Product Development, Quality Assurance, Quality Control, Quality Metrics, Regulations, Regulatory Requirements, Supply Chain, Technical Operations, Test Lab, Willing to Travel, Writing Skills

LOCATION

Waltham, MA

POSTED

28 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 Vice President, Analytical Development & Quality Control is the enterprise leader accountable for Ardelex’s analytical chemistry activities. Reporting to the Chief Technical Operations Officer, the VP of AD/QC will provide oversight of Ardelyx’s array of contract testing laboratories across the company’s portfolio of development-stage projects and commercial products. The VP of AD/QC will build, improve, and scale a modern, inspection ready analytical chemistry capability that ensures reliable supply, strengthens compliance, and champions a proactive, high-engagement technical and quality culture across internal teams and external partners.Responsibilities:Partner with other functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs) to develop and implement appropriate control strategies for all stages of product development and manufacturingLead and collaborate with other departments to implement quality and process improvement initiativesOversee the development, validation, implementation, and life-cycle management of analytical methods for the analysis of raw materials, intermediates, drug substance, and drug productEnsure that all AD/QC activities are conducted in stage-appropriate accordance with current Good Manufacturing Practices (cGMPs) and relevant regulatory requirementsAuthor and review IND/NDA Module 3 sections, with primary responsibility for Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, and StabilityManage and develop a team of skilled professionals, providing mentorship and fostering a culture of excellence, innovation, collaboration, and teamworkDevelop and maintain productive relationships with outsourced analytical testing partners, actively managing all associated activitiesAllocate internal and external resources effectively to meet departmental and corporate timelines and objectivesDevelop and monitor Key Performance Indicators (KPIs) for the AD/QC departmentCollaborate with QA in the preparation and presentation of reports to management on quality-related metrics and compliance status Qualifications:15+ years pharmaceutical industry experience, with a strong background in the AD and QC functions, phase-appropriate requirements, and at least 10 years of experience in a managerial role, or equivalent experienceProven track record of successful collaboration with key stakeholder functions (e.g. Supply Chain, CMC, Quality Assurance, and Regulatory Affairs)In-depth knowledge of current regulatory requirements and guidelines for analytical development and quality control (cGMP, ICH, FDA, etc.)Direct experience as a lead author of relevant Module 3 sections and supporting regulatory authority inspectionsExperience with computerized systems (e.g. LIMS, Veeva, etc.) and their associated compliance requirementsStrong technical problem-solving and decision-making skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organizationWork Environment:The position is based in our Waltham, MA office and requires onsite presence 2-3 days per week.The ability to travel to Ardelyx’s other locations and external testing labs is required (up to 20 %) The anticipated annualized base pay range for this full-time position is $302,000 - $370,000 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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