Senior Quality Assurance Manager

7 days ago

Fremont, California, United States Ardelyx Full time

Ardelyx is a biopharmaceutical company dedicated to developing innovative medicines. With two commercial products approved in the US, we strive to meet unmet medical needs globally. Our product tenapanor has been submitted for approval in China and is commercialized in Japan by Kyowa Kirin.

">Job Overview

We are seeking a skilled QA Specialist III to provide quality support for our operations. As a key member of our team, you will work in a fast-paced pharmaceutical environment with diverse responsibilities. Your focus will be on QA activities, requiring strong skills sets and experience.

Responsibilities
  • Support quality metric reporting for management reviews and KPIs.
  • Implement quality risk management frameworks.
  • Review batch records and perform dispositions for clinical trials, registration, validation, and commercial distribution.
  • Evaluate CMO manufacturing records for accuracy and completeness.
  • Maintain Continued Process Verification data in real-time at batch release.
  • Review Quality System documentation, including deviations, OOS, product complaints, CAPAs, and document controls.
  • Evaluate document changes for compliance requirements.
  • Analyze and report product and process quality trends against internal and external guidelines.
  • Support QA CMO oversight activities to ensure quality standards are maintained.
  • Liaise with Regulatory Affairs on manufacturing process changes impacting regulatory filings.
  • Collaborate with CMC to improve compliance with quality systems and regulations.
  • Support product complaint-handling activities.
  • Prepare the Annual Product Quality Report.
  • Conduct cGMP compliance audits of GMP suppliers' quality systems.
  • Provide training for employees as needed.
Requirements
  • Bachelor's degree in science or equivalent relevant experience.
  • 7+ years of combined GxP experience in drug substance and drug product manufacturing, development, and/or quality control in biotechnology or pharmaceutical industries.
  • Experience in a manufacturing setting as a Quality person in the plant (QA PIP).
  • Working knowledge of quality risk assessment management principles.
  • Extensive knowledge of GMP regulations and guidance.
  • Extensive experience with Quality Assurance systems and processes.
  • Effective organization and planning skills.
  • Demonstrated ability to handle frequent changes and pressure.
  • Strong technical writing skills.
  • Advanced software skills, including SharePoint, Visio, Project, Acrobat Pro, and Veeva.
  • Strategic planning, leadership, and negotiation skills.
  • Ability to work independently and under tight deadlines.

The salary range for this full-time position is $91,217 - $111,487. Ardelyx offers competitive compensation aligned with industry peers. The actual base pay will be determined based on factors like experience, qualifications, and internal equity. A comprehensive benefits package includes a 401(k) plan, paid parental leave, living organ and bone marrow leave, equity awards, health plans, life insurance, disability, flexible time off, and holidays.

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