Senior Quality Ops Lead, External Manufacturing

Ardelyx, Inc.; Waltham (MA); Hybrid; USD 148,000 - 180,000; Full time

Benefits offered by this job

401(k) match

Parental leave

Organ & marrow leave

Equity awards

Health insurance

Flexible time off

Holiday shutdown

Paid holidays

Job summary

Ardelyx, Inc. seeks a Senior Quality Operations Manager to oversee external manufacturing and quality systems, ensuring compliance with company standards and regulatory requirements.

You will coordinate with CMOs, suppliers, contract labs, and alliance partners to maintain quality governance and issue resolution. You will collaborate with Technical Operations, Manufacturing, Supply Chain, and Regulatory Affairs to support tech transfers, analytical activities, and product supply, while leading

Qualifications

• 8+ years of Quality experience in pharma/biotech.
• Experience overseeing CMOs, suppliers, or alliance partners.
• Strong knowledge of cGMP and global regulations.
• Experience with Quality agreements, deviations, CAPAs, change controls, APQRs.
• Working knowledge of analytical/ QC operations and method transfer.

Responsibilities

• Provide day-to-day Quality oversight of external partners and sites.
• Coordinate resolution of Quality issues and escalation pathways.
• Draft and monitor Quality agreements and amendments.
• Review deviations, investigations, CAPAs, and change controls.
• Oversee technology transfers, method transfers, validation, and transfer readiness.
• Oversee QC activities, specifications, stability programs, and investigations.
• Support APQRs with data collection and trend analysis.
• Monitor partner Quality metrics and drive continuous improvement.
• Support quality governance meetings and regulatory inspections.
• Maintain timely Quality documentation and risk reporting.

Skills

Quality Management

Regulatory Knowledge

Project Management

Cross-functional Collaboration

Communication

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Ardelyx, Inc. seeks a Senior Quality Operations Manager to oversee external manufacturing and quality systems, ensuring compliance with company standards and regulatory requirements.

You will coordinate with CMOs, suppliers, contract labs, and alliance partners to maintain quality governance and issue resolution. You will collaborate with Technical Operations, Manufacturing, Supply Chain, and Regulatory Affairs to support tech transfers, analytical activities, and product supply, while leading