Hybrid Quality Operations Leader - External Manufacturing

Ardelyx, Inc.; Newark (CA); Hybride; USD 148 000 - 180 000; Plein temps

Avantages offerts par ce poste

401(k) match

Paid parental leave

Equity incentive plans

Health plans

Résumé du poste

Ardelyx, Inc. is seeking a Senior Quality Operations Manager to oversee external manufacturing partners, CMOs, and contract labs.

Reporting to the Executive Director, External Operations Quality, you will ensure compliance with company standards, quality agreements, and regulatory requirements while guiding cross-functional teams. You will drive quality governance, manage deviations and CAPAs, support tech transfers and product readiness, and maintain rigorous documentation.

Qualifications

• Bachelor’s degree (life sciences, chemistry, engineering, pharmacy) with 8+ years quality experience.
• Experience overseeing CMOs, suppliers, contract laboratories, service providers, or alliance partners.
• Strong knowledge of cGMP requirements, pharmaceutical quality systems, and 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 travel domestically and internationally up to 25%.

Responsabilités

• 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.

Connaissances

Quality Oversight

CMO Management

Regulatory Knowledge

CAPA & Investigations

Technology Transfer

Documentation

Project Management

Formation

Life Sciences Degree

Outils

Quality Systems

GxP Software

Description du poste

Ardelyx, Inc. is seeking a Senior Quality Operations Manager to oversee external manufacturing partners, CMOs, and contract labs.

Reporting to the Executive Director, External Operations Quality, you will ensure compliance with company standards, quality agreements, and regulatory requirements while guiding cross-functional teams. You will drive quality governance, manage deviations and CAPAs, support tech transfers and product readiness, and maintain rigorous documentation.