Summary

The Senior Quality Operations Manager provides day-to-day Quality oversight of CMOs, suppliers, contract laboratories, service providers, and alliance partners. Reporting to the Executive Director, External Operations Quality, this role serves as a key Quality contact for external partners and ensures compliance with company standards, Quality agreements, and applicable regulatory requirements. The Senior Manager partners with Technical Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, and Regulatory Affairs to support external manufacturing, technology transfer, analytical activities, and product supply, including the identification, escalation, and resolution of Quality issues.

Job description

Position Summary

The Senior Quality Operations Manager provides day-to-day Quality oversight of CMOs, suppliers, contract laboratories, service providers, and alliance partners. Reporting to the Executive Director, External Operations Quality, this role serves as a key Quality contact for external partners and ensures compliance with company standards, Quality agreements, and applicable regulatory requirements. The Senior Manager partners with Technical Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, and Regulatory Affairs to support external manufacturing, technology transfer, analytical activities, and product supply, including the identification, escalation, and resolution of Quality issues.

Responsibilities

Provide day-to-day Quality oversight of CMOs, suppliers, contract laboratories, service providers, and alliance partners
Serve as a primary operational Quality contact for external partners and coordinate the 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
Provide Quality oversight of technology transfers, analytical method transfers, validation activities, and manufacturing readiness
Provide Quality oversight of analytical and QC activities, including specifications, stability programs, method validation and transfer, and laboratory investigations
Coordinate and support 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 initiatives
Support partner qualifications, audits, quality governance meetings, inspection readiness, and regulatory inspections
Maintain accurate and timely Quality documentation and communicate significant risks and issues to Quality leadership
Collaborate across functions to support compliant manufacturing and continuity of product supply

Requirements

Bachelor’s degree, advanced degree preferred, in life sciences, chemistry, engineering, pharmacy, or a related discipline
8+ years of Quality experience within the pharmaceutical or biotechnology industry, or equivalent experience
Experience overseeing CMOs, suppliers, contract laboratories, service providers, or alliance partners
Strong knowledge of cGMP requirements, pharmaceutical Quality systems, and applicable global regulations
Experience with Quality agreements, deviations, investigations, CAPAs, change controls, technology transfers, and APQRs
Working knowledge of analytical and QC operations, including method transfer, validation, stability, specifications, and laboratory investigations
Strong project management, communication, collaboration, and problem-solving skills
Ability to manage multiple priorities, exercise sound judgment, and influence internal and external stakeholders
Ability to travel domestically and internationally up to 25%

Benefits

401(k) Matching
Paid Parental Leave
Living Organ Leave
Equity Incentive Plans
Health Plans
Life Insurance
Disability Insurance
Flexible Time Off
Winter Holiday Shutdown
Paid Holidays

Company overview

Ardelyx, Inc. is a biopharmaceutical company founded in 2007 and headquartered in Fremont, California, with additional offices in Waltham, Massachusetts. The company specializes in discovering, developing, and commercializing innovative, first-in-class medicines that address significant unmet medical needs. Ardelyx has developed a unique platform that enables the discovery of novel biological mechanisms and pathways to create potent and efficacious therapies while minimizing side effects and drug-drug interactions commonly associated with traditional systemically absorbed medicines. The company currently has two FDA-approved commercial products: IBSRELA® (tenapanor) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C), and XPHOZAH® (tenapanor) for reducing serum phosphorus in adults with chronic kidney disease on dialysis. Ardelyx has established strategic partnerships for international commercialization, including agreements with Kyowa Kirin in Japan and Fosun Pharma in China. As a publicly traded company on NASDAQ under the symbol ARDX, Ardelyx employs approximately 201-500 professionals and continues to advance its pipeline of gastrointestinal and renal disease therapeutics.