Executive Director - Analytical Development & Quality Control

1d1 day ago

Ardelyx

Waltham, US · Full-time · $267,000 – $327,000

About this role

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. The Executive Director, Analytical Development & Quality Control serves as the enterprise leader accountable for all analytical chemistry activities. Reporting to the Chief Technical Operations Officer, the role oversees contract testing laboratories supporting development-stage projects and commercial products.

The position provides strategic oversight for method development, validation, and life-cycle management of analytical methods for raw materials, drug substance, and drug product. It ensures all activities meet stage-appropriate cGMP requirements and regulatory standards while partnering with Supply Chain, CMC, Quality Assurance, and Regulatory Affairs on control strategies.

The Executive Director manages a team of skilled professionals and cultivates relationships with outsourced analytical testing partners. Responsibilities include allocating resources, monitoring departmental KPIs, and collaborating with QA on quality metrics and compliance reporting to management.

Ardelyx fosters an inclusive environment where employees are respected, supported, and empowered to make an impact. The role builds a proactive, high-engagement technical and quality culture across internal teams and external partners while aligning the AD/QC roadmap with overall company objectives.

Requirements

An advanced degree (MS or Ph.D.) in Chemistry or a related discipline
12+ years pharmaceutical industry experience with a strong background in the AD and QC functions and phase-appropriate requirements
At least 10 years of experience in a managerial role, or equivalent experience
Proven track record of successful collaboration with key stakeholder functions including Supply Chain, CMC, Quality Assurance, and Regulatory Affairs

Responsibilities

Provide strategic roadmap for the AD/QC department, aligning it with overall company objectives and regulatory requirements
Partner with Supply Chain, CMC, Quality Assurance, and Regulatory Affairs to develop and implement control strategies for all stages of product development and manufacturing
Oversee the development, validation, implementation, and life-cycle management of analytical methods for raw materials, intermediates, drug substance, and drug product
Ensure all AD/QC activities are conducted in stage-appropriate accordance with 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 while actively managing all associated activities
Develop and monitor Key Performance Indicators for the AD/QC department and collaborate with QA on quality-related metrics and compliance status