Senior Quality Operations Leader, External Partnerships

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

Benefits offered by this job

401(k) match

Parental leave (12 weeks)

Organ and bone marrow leave (12 weeks)

Equity incentives

Health plans (medical, dental, vision)

Life insurance & disability

Flexible time off

Winter shutdown

Paid holidays

Job summary

Ardelyx is seeking a Senior Quality Operations Manager to provide day-to-day Quality oversight for external manufacturing, labs, and service providers. You will ensure compliance with QMS, quality agreements, and regulatory requirements while collaborating with Technical Operations, Manufacturing, and Regulatory Affairs.

The role supports technology transfers, analytical method transfers, and manufacturing readiness, and requires strong project management, communication, and problem-solving

Qualifications

• Bachelor's degree with 8+ years of Quality experience in pharm/biotech.
• Experience overseeing CMOs, suppliers, contract labs, service providers or alliance partners.
• Strong knowledge of cGMP requirements, pharma Quality systems and global regulations.
• Experience with Quality agreements, deviations, investigations, CAPAs, change controls, tech transfers and APQRs.
• Working knowledge of analytical and QC operations including method transfer, validation, stability, specs, and lab investigations.
• Strong project management, communication, collaboration and problem-solving skills.
• Ability to travel domestically and internationally up to 25%.

Responsibilities

• Provide day-to-day Quality oversight of external partners (CMOs, suppliers, labs, service providers).
• Serve as primary Quality contact for external partners and coordinate resolution of Quality issues.
• Draft, negotiate, maintain and monitor Quality agreements.
• Review external deviations, investigations, change controls, CAPAs, and effectiveness checks.
• Oversee tech transfers, analytical method transfers, validation activities and manufacturing readiness.
• Oversee analytical and QC activities including specs, stability programs and investigations.
• Coordinate Annual Product Quality Reviews (APQRs) data collection and follow-ups.
• Monitor external partner Quality metrics, trends and risks; support continuous improvement.
• Support partner qualifications, audits, governance meetings, inspections readiness and regulatory inspections.
• Maintain accurate Quality documentation and escalate significant risks to leadership.
• Collaborate across functions to ensure compliant manufacturing and continuity of supply.

Skills

Quality oversight

Regulatory knowledge

Project management

Cross-functional collaboration

Quality systems

Communication

Problem-solving

Travel readiness

Education

Bachelor's degree in life sciences or related

Advanced degree preferred

Job description

Ardelyx is seeking a Senior Quality Operations Manager to provide day-to-day Quality oversight for external manufacturing, labs, and service providers. You will ensure compliance with QMS, quality agreements, and regulatory requirements while collaborating with Technical Operations, Manufacturing, and Regulatory Affairs.

The role supports technology transfers, analytical method transfers, and manufacturing readiness, and requires strong project management, communication, and problem-solving