Executive Director, Quality Operations

Role Summary

Executive Director, Quality Operations. Direct all aspects of Quality Operations including Process Quality Assurance and Analytical Quality. Provide strategic direction to the Quality Process and Quality Analytical teams, lead GMP batch review, disposition, CMO deviations and change management programs for API, drug product and finished goods, and oversee annual stability, release testing, data trending, method validation, and oversight of contract test labs. 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
• Drive engagement to ensure personnel have clear expectations, appropriate tools and information, and opportunities to grow; recognize team contributions
• Ensure adequate and compliant investigations into OOT/OOS results generated at contract test labs
• Ensure compliance with applicable post market requirements for annual stability testing of designated batches as per regulatory commitments
• Partner with Technical Operations and Regulatory Affairs on development projects, method and process transfer/optimization and validation program requirements
• Establish data trending programs across products to proactively identify and investigate trends and report trending outcomes at Quality Management Review and other forums
• Drive systemic process change as a result of deviations/investigations and other quality trends
• Help define department objectives to align with corporate goals
• Keep management informed on product quality and other concerns such as supplier quality issues and deviations
• Assure appropriate systems and processes 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 to facilitate resolution of quality and technical issues
• Evaluate and approve compliance documentation including regulatory filings for Ardelyx products
• Collaborate with Ardelyx international business partners as needed
• Develop budget forecasts and track QA expenses

Qualifications

• Bachelor‚Äôs degree with 15+ years of related experience, preferably in life sciences with at least ten years of Quality Assurance and Analytical experience in development and commercial programs
• Strong expertise in US FDA regulations and guidance with emphasis on compliance and direct experience with regulatory submissions
• Experience with 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 experience influencing across the organization to improve product or processes
• Proven ability to identify quality issues/discrepancies through a risk-based approach and resolve them in a diplomatic, flexible, constructive manner
• Knowledge of Regulations, 21CFR 210/211, ICH Guidelines
• Ability to manage shifting priorities to meet critical deadlines in a fast-paced, dynamic environment
• Strong written and verbal communication skills
• Ability to travel domestically and internationally up to 15%

Education

• Not specified beyond degree requirements in Qualifications

Additional Requirements

• Work location: Newark, CA