Executive Director, Quality Operations

Role Summary

The Executive Director, Quality Operations directs all aspects of Quality Operations, including GMP Quality Assurance and Quality Control. Provides strategic direction to Quality Process and Quality Analytical teams, leads GMP batch review, disposition, and change management programs for API, drug product, and finished goods, and oversees Quality Control activities including stability, release testing, data trending, method validation, and oversight of contract labs and investigations. Supports development projects within Ardelyx.

Responsibilities

• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to Ardelyx Quality Policies and procedures
• Support the development of a proactive quality systems culture throughout the business
• Establish a high-performing team to drive organizational goals and instill a robust quality culture
• Ensure adequate and compliant investigations into OOT/OOS results at contract test labs
• Ensure compliance with post-market requirements for annual stability testing
• Partner with Technical Operations and Regulatory Affairs on development projects, transfer/optimization, and validation requirements
• Establish data trending programs and report outcomes at QMR and other forums
• Drive systemic process changes based on deviations/investigations and trends
• Help define department objectives aligned with corporate goals
• Keep management informed on product quality and supplier quality issues
• Ensure systems and processes for assessing product impact, investigations, and closure of deviations and audit observations
• Sponsor quality and technical projects with third-party suppliers; collaborate with internal stakeholders and GxP partners
• Evaluate and approve compliance documentation including regulatory filings
• Collaborate with international partners as needed
• Develop budget forecasts and track QA expenses

Qualifications

• Bachelor‚Äôs degree with 15+ years in life sciences; at least 10 years in Quality Assurance and Quality Control in development and commercial programs or equivalent
• Strong expertise in US FDA regulations and guidance with experience in regulatory submissions
• Experience hosting, leading, and managing US regulatory agency inspections (preferred)
• Strong analytical skills including trend and statistical analysis
• Ability to communicate and interact with all levels of the organization including Executive Leadership
• Interpersonal skills for coaching, training, and direction
• Proven ability to influence across the organization to improve products or processes
• Ability to identify quality issues via a risk-based approach and resolve them constructively
• Regulations: 21 CFR 210/211, ICH Guidelines
• Ability to manage shifting priorities in a fast-paced environment
• Strong written and verbal communication skills
• Ability to travel domestically and internationally up to 15%

Work Environment

• East Coast Hybrid or local to Waltham, MA