Executive Director, Quality Operations

Role Summary

Executive Director, Quality Operations will direct all aspects of Quality Operations including GMP Quality Assurance and Quality Control within Ardelyx. The role provides strategic direction to the Quality Process and Quality Analytical teams, leads GMP batch review, disposition, CMO deviations and change management programs for API, drug product and finished goods, and oversees all aspects of Quality Control including annual stability, release testing, data trending, method validation, and oversight of contract test labs and TOIs. May support 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 of designated batches
• Partner with Technical Operations and Regulatory Affairs on development projects, transfer/optimization and validation programs
• Establish data trending programs to identify and investigate trends and report outcomes at Quality Management Review
• Drive systemic process change from deviations/investigations and other quality trends
• Define department objectives aligned with corporate goals
• Keep management informed on product quality and supplier quality issues, deviations
• Ensure systems are in place for assessing product impact, investigation, follow-up 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 for Ardelyx products
• Collaborate with international business partners as needed
• Develop budget forecasts and track QA expenses

Qualifications

• Bachelor‚Äôs degree with 15+ years of related experience in life sciences; minimum 10 years of Quality Assurance and Quality Control experience in development and commercial programs or equivalent
• Strong expertise in US FDA regulations and guidance with emphasis on compliance and 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
• Strong interpersonal skills to provide coaching, training, and direction
• Proven ability to influence across the organization to improve products or processes
• Proven ability to identify quality issues/discrepancies using a risk-based approach and resolve them constructively
• Knowledge of regulations, 21CFR 210/211, ICH Guidelines
• Ability to manage shifting priorities to meet deadlines in a fast-paced environment
• Strong written and oral communication skills
• Ability to travel domestically and internationally up to 15%

Skills

• Quality management systems
• Regulatory compliance and submissions
• Quality assurance and quality control leadership
• Data trending and statistical analysis
• Risk management and issue resolution
• Vendor and contract lab oversight

Education

• Bachelor‚Äôs degree required; advanced degree preferred

Additional Requirements

• Work location: East Coast Hybrid or local to Waltham, MA