Senior Quality Operations Manager

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

Description

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.

Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.

We foster an inclusive environment where employees are respected, supported, and empowered to make an impact - both within our company and in the lives of patients we serve.

This is hybrid role with 2-3 days per week onsite in our Waltham, MA or Newark, CA office.

Position Summary

The Senior Quality Operations Manager provides day-to-day Quality oversight of CMOs, suppliers, contract laboratories, service providers, and alliance partners. Reporting to the Executive Director, External Operations Quality, this role serves as a key Quality contact for external partners and ensures compliance with company standards, Quality agreements, and applicable regulatory requirements.

The Senior Manager partners with Technical Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, and Regulatory Affairs to support external manufacturing, technology transfer, analytical activities, and product supply, including the identification, escalation, and resolution of Quality issues.

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 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

Qualifications

• Bachelor's degree, advanced degree preferred, in life sciences, chemistry, engineering, pharmacy, or a related discipline with 8+ years of Quality experience within the pharmaceutical or biotechnology industry.
• Experience overseeing CMOs, suppliers, contract laboratories, service providers, or alliance partners
• Strong knowledge of cGMP requirements, pharmaceutical Quality systems, and applicable 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 manage multiple priorities, exercise sound judgment, and influence internal and external stakeholders
• Ability to travel domestically and internationally up to 25%

The anticipated annualized base pay range for this full-time position is $148,000 - $180,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.