Vice President, Analytical Development & Quality Control

Ardelyx•Waltham, MA

5d•$302,000 - $370,000•Hybrid

About The Position

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 (AD/QC), 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.

Requirements

An advanced degree (MS or Ph.D.) in Chemistry or a related discipline
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 experience
Proven 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 inspections
Experience with computerized systems (e.g. LIMS, Veeva, etc.) and their associated compliance requirements
Strong 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 organization

Responsibilities

Provide strategic direction and vision for the AD/QC department, aligning it with the overall company objectives and regulatory requirements
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 manufacturing
Lead and collaborate with other departments to implement quality and process improvement initiatives
Oversee the development, validation, implementation, and life-cycle management of analytical methods for the analysis of raw materials, intermediates, drug substance, and drug product
Ensure that all AD/QC activities are conducted in stage-appropriate accordance with current Good Manufacturing Practices (cGMPs) and relevant regulatory requirements
Author and review IND/NDA Module 3 sections, with primary responsibility for Characterization/Impurities, Analytical Methods/Validation, Batch Analysis, Specifications, and Stability
Manage and develop a team of skilled professionals, providing mentorship and fostering a culture of excellence, innovation, collaboration, and teamwork
Develop and maintain productive relationships with outsourced analytical testing partners, actively managing all associated activities
Allocate internal and external resources effectively to meet departmental and corporate timelines and objectives
Develop and monitor Key Performance Indicators (KPIs) for the AD/QC department
Collaborate with QA in the preparation and presentation of reports to management on quality-related metrics and compliance status