Senior Quality Operations Manager, External Partners

Ardelyx, Inc.; Northern (KY); Hybrid; USD 148,000 - 180,000; Full time

Benefits offered by this job

401(k) plan with generous employer max

12 weeks of paid parental leave

up to 12 weeks of living organ andbone

equity incentive plans

health plans (medical, prescription,  

life insurance and disability

flexible time off

annual Winter Holiday shut down

at least 11 paid holidays

Job summary

Ardelyx, Inc. is seeking a Senior Quality Operations Manager to provide day-to-day quality oversight of CMOs, suppliers, contract laboratories, service providers, and alliance partners.

You will be a primary Quality contact for external partners and ensure compliance with company standards and applicable regulatory requirements. You will collaborate with Technical Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, and Regulatory Affairs to support external

Qualifications

• Bachelor’s degree in life sciences, engineering, pharmacy or related discipline with 8+ years of Quality experience.
• Experience overseeing CMOs, suppliers, contract laboratories, service providers or alliance partners.
• Strong knowledge of cGMP requirements and global regulations.
• Experience with quality agreements, deviations, investigations, CAPAs, change controls and APQRs.

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 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 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.

Skills

Quality management

cGMP knowledge

Regulatory compliance

Vendor/CMO oversight

Project management

Communication

Risk assessment

Travel up to 25%

Education

Bachelor's degree in life sciences/engineering/pharmacy

Job description

Ardelyx, Inc. is seeking a Senior Quality Operations Manager to provide day-to-day quality oversight of CMOs, suppliers, contract laboratories, service providers, and alliance partners.

You will be a primary Quality contact for external partners and ensure compliance with company standards and applicable regulatory requirements. You will collaborate with Technical Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, and Regulatory Affairs to support external