Senior Quality Operations Manager
About The Position
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.
Requirements
- 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, or equivalent experience
- 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%
Nice To Haves
- advanced degree preferred
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
Benefits
- 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
- at least 11 paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
