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 Associate Director, Quality Management Systems is responsible for leading process improvements and change for Quality Management System (QMS) processes. This also includes leading and managing Vendor Quality (Qualification, Audits, and Quality Agreements), Internal Audits, Internal Deviations, CAPAs and Product Quality Complaints. Associate Director will manage and lead Quality Metrics reporting to various QMS boards and Management Review meetings to Quality Leadership and Senior Leadership. This role will report to the Executive Director, Quality Management and GXP Systems.

QUALIFICATIONS:

• Bachelor’s degree in science with 10+ years of GxP Quality experience in life sciences industry or equivalent relevant experience
• 5+ years of hands-on experience in GxP vendor audits and hosting external audits and inspections
• Ability to manage projects and lead cross-functional teams in a fast-paced environment
• Demonstrated experience in leading, managing and improving pharmaceutical quality systems
• Strong leadership, technical, management, problem solving and project management skills
• Ability to quickly understand issues, needs and articulate potential solutions
• Excellent communication and time management skills
• Good presentation, verbal and written communication skills
• Understanding of CFR Title 21 (Parts 11, 210, and 211)
  The anticipated annualized base pay range for this full-time position is $185,000 - $227,000. 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.

• Lead and project manage Quality Management Continuous Improvement projects based on strategy and timelines, including managing cross functional teams and implementing change/training plans
• Implement, lead and coordinate periodic Quality Board meetings with cross functional GXP team members reporting status and progress of Quality Events/CAPA, Product Complaints, Supplier Quality/Audit, SOP/Training and QMS Improvement projects
• Lead, coordinate and present the reporting of Quality metrics on a weekly, monthly, and quarterly basis for reporting at various forums (QMS boards and Management Review) and Quality Leadership team
• Lead and manage activities for quarterly Management Review meetings which include Quality Metrics and project status
• Lead and manage Vendor Quality Program including vendor assessment/qualification, vendor audits, and establishing & updates required for Quality Agreements with vendors
• Manage and lead auditors/third party auditors ensuring adherence to annual audit schedule and audit reviews/approvals, including improving our Vendor Quality Program and Audit processes
• Lead, manage and coordinate GXP internal audits with the business along with monitoring CAPA closure and ensuring audits are completed as per annual audit schedule
• Lead and manage inspection readiness activities and mock inspections. Lead and host external audits and regulatory inspections. Backroom lead for document requests and communication to front room. Also support as SME for regulatory inspections.
• Manage, review, approve and monitor internal deviations and CAPA records to completion through cross functional teamwork and continuously improve deviation/CAPA processes
• Streamline and improve Complaint process partnering with cross functional team members, including manage, review, approve and coordinate with cross functional team members (PV, QA Operations and Clinical Operations) Product Complaint Process and ensuring robust and compliant processes managing product complaint handling which includes comprehensive investigation and CAPAs
• Lead and manage other related duties and projects as assigned based on business needs
• Lead and manage direct reports and consultants/contractors, as needed, to complete QMS milestones