Senior Quality Operations Manager

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 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.