Executive Director, Quality Operations at Ardelyx

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 proceduresSupport the development of a proactive quality systems culture throughout the businessEstablish a high-performing team to drive organizational goals & objectives and instill a robust quality cultureDrive 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 contributionsEnsure 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 agencyPartner with Technical Operations and Regulatory Affairs on development projects, method and process transfer/optimization and validation program requirementsEstablish data trending programs across products to proactively identify and investigate trends and report trending outcomes at Quality Management Review and other forumsDrive systemic process change as a result of deviations/investigations and other quality trendsHelp define department objectives to align with corporate goalsKeep management informed on product quality and other concerns such as supplier Quality issues, deviationsAssure appropriate systems and processes are in place for assessing product impact, investigation, follow up and closure of deviations and audit observationsSponsor quality and technical projects with third party suppliers; collaborating with internal stakeholders and GxP partners to facilitate resolution of quality and technical issuesEvaluate and approve compliance documentation including regulatory filings for Ardelyx productsCollaborate with Ardelyx international business partners as neededDevelop budget forecasts and track QA expensesQualifications: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 programsMust have strong expertise in US FDA regulations and guidance with a strong emphasis on compliance and direct experience with regulatory submissionsExperience with hosting, leading and managing US regulatory agency inspections preferredStrong analytical skills including trend and statistical analysisDemonstrated ability to communicate and interact with all levels of the organization including Executive LeadershipStrong interpersonal skills to provide coaching, training, and directionProven experience influencing across the organization to improve product or processesProven 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 mannerKnowledge of Regulations, 21CFR 210/211, ICH GuidelinesMust be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environmentMust have strong written and communication skillsAbility to travel domestically and internationally up to 15%Work Environment:Newark, CAThe anticipated annualized base pay range for this full-time position is $270,000-$330,000. 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.