Senior Quality Operations Lead - External Manufacturing

Ardelyx

Newark (CA)

Hybrid

USD 148,000 - 180,000

Full time

12 days ago

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Benefits offered by this job

401(k) match

Paid parental leave

Org./bone marrow leave (12 weeks)

Equity incentives

Medical, prescription drug, dental, &-

Job summary

Ardelyx is seeking a Senior Quality Operations Manager to provide day-to-day quality oversight of CMOs, suppliers, contract labs, and alliance partners. You will ensure compliance with company standards, quality agreements, and regulatory requirements.

You will partner with Technical Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, and Regulatory Affairs to support external manufacturing, tech transfers, and product supply, escalating quality issues as needed.

Qualifications

Bachelor's degree in life sciences or related field; advanced degree preferred.
8+ years of quality experience in pharmaceutical/biotechnology sectors.
Experience overseeing CMOs, suppliers, or external partners.
Strong knowledge of cGMP and global regulatory requirements.
Experience with quality agreements, deviations, investigations, CAPAs, change controls, APQRs.
Knowledge of analytical and QC operations including method transfer and validation.
Strong project management, communication, collaboration and problem-solving skills.
Willingness to travel up to 25% domestically and internationally.

Responsibilities

Provide day-to-day Quality oversight of CMOs, suppliers, contract labs, service providers, and alliance partners.
Serve as a primary operational Quality contact for external partners and coordinate issue resolution.
Draft, negotiate, maintain, and monitor Quality agreements.
Review external deviations, investigations, CAPAs, change controls, and APQRs.
Oversee technology transfers, analytical method transfers, validations, and manufacturing readiness.
Oversee analytical and QC activities, including specifications and stability programs.
Coordinate Annual Product Quality Reviews (APQRs) data collection and trending.
Monitor external partner Quality metrics and drive continuous improvement.
Support partner qualifications, audits, governance meetings, and regulatory inspections.
Maintain Quality documentation and communicate risks to leadership.
Collaborate across functions to ensure compliant manufacturing and supply continuity.