Executive Director, Quality Operations

Description

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.

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

Qualifications:

• Bachelors 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%

Work Environment:

Newark CA

The anticipated annualized base pay range for this full-time position is $270000-$330000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision)life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

Required Experience:

Director