Senior Quality Operations Manager

Ardelyx•Waltham, MA

12d•Hybrid

About The Position

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve. This is hybrid role with 2-3 days per week onsite in our Waltham, MA or Newark, CA office. 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.

Requirements

Bachelor’s degree, advanced degree preferred, in life sciences, chemistry, engineering, pharmacy, or a related discipline with 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%

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