Senior Quality Operations Manager

About the role

Ardelyx, a commercial-stage biopharmaceutical company, is hiring a Senior Quality Operations Manager in Waltham, Massachusetts. The role provides day-to-day Quality oversight of CMOs, suppliers, contract laboratories, service providers and alliance partners, reporting to the Executive Director, External Operations Quality. It is a hybrid position with 2-3 days per week onsite in the Waltham, MA or Newark, CA office.

Key responsibilities

• Oversee Quality for external partners and act as their primary operational Quality contact, coordinating resolution and escalation of Quality issues
• Draft, negotiate, maintain and monitor compliance with Quality agreements
• Review and oversee external deviations, investigations, change controls, CAPAs and effectiveness checks
• Oversee technology transfers, analytical method transfers, validation activities and manufacturing readiness
• Oversee analytical and QC activities, including specifications, stability programs, method validation and transfer, and laboratory investigations
• Coordinate Annual Product Quality Reviews (APQRs), including data collection, trend analysis and follow-up actions
• Monitor external partner Quality metrics, identify trends and risks, and support continuous improvement
• Support partner qualifications, audits, quality governance meetings, inspection readiness and regulatory inspections
• Maintain accurate Quality documentation and communicate significant risks to Quality leadership

Required profile

• Bachelor's degree, advanced degree preferred, in life sciences, chemistry, engineering, pharmacy or a related field
• 8+ years of Quality experience in the pharmaceutical or biotechnology industry
• Experience overseeing CMOs, suppliers, contract laboratories, service providers or alliance partners
• Ability to travel domestically and internationally up to 25%

Required skills

• Strong knowledge of cGMP requirements, pharmaceutical Quality systems and global regulations
• Quality agreements, deviations, investigations, CAPAs, change controls, technology transfers and APQRs
• Analytical and QC operations, including method transfer, validation, stability, specifications and laboratory investigations
• Project management, communication, collaboration and problem-solving

What we offer

• Anticipated annualized base pay of $148,000 - $180,000, with possible annual bonus target and equity awards
• 401(k) with employer match, 12 weeks of paid parental leave, equity incentive plans
• Health, dental, vision, life insurance and disability coverage
• Flexible time off, annual Winter Holiday shut down and at least 11 paid holidays