Executive Director, Quality Operations

Ardelyx•Newark, CA

16d•$270,000 - $330,000•Onsite

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 position will direct all aspects of Quality Operations including Process Quality Assurance and Analytical Quality within Ardelyx. The Head of Quality Operations will provide strategic direction to the Quality Process and Quality Analytical teams. This role will lead the GMP batch review, disposition, CMO deviations and change management programs for API, drug product and finished goods as well as lead all aspects of Quality Analytical including the annual stability program, release testing, trending of data, method validation, compliance and oversight of contract test labs and laboratory out of trend and out of specification investigations. Additionally, the Head of Quality Operations will support development projects within Ardelyx.

Requirements

Bachelor’s degree with 15+ years of related experience, preferably in life sciences with a minimum of ten years of Quality Assurance and Analytical experience in development and commercial programs
Must have strong expertise in US FDA regulations and guidance with a strong 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
Demonstrated 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 effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner
Knowledge of Regulations, 21CFR 210/211, ICH Guidelines
Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment
Must have strong written and communication skills
Ability to travel domestically and internationally up to 15%

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 & objectives and instill a robust quality culture
Drive engagement to ensure personnel have clear expectations, appropriate tools and information, and opportunity to share, grow and develop and team members are recognized for their 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 commitment to regulatory agency
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, 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; collaborating 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