DescriptionThis 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.
