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Executive Director, External Operations Quality

Ardelyx

Job Location:

Waltham, MA - USA

Yearly Salary: USD 267000 - 327000

Posted: 29 September 2026 (8 hours ago)

Application Deadline: 27 December 2026

Vacancies: 1 Vacancy

Job Summary

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 Executive Director External Operations Quality provides strategic and operational leadership for quality oversight of the companys external manufacturing network. This senior Quality leader serves as the primary conduit between the company and all external manufacturing sites including contract development and manufacturing organizations (CMOs) contract testing laboratories packaging and labeling providers and other critical external partners and providers.

The Executive Director is accountable for ensuring externally manufactured products and materials consistently meet company quality standards regulatory requirements supply commitments and patient needs. The role establishes quality governance across the external network strengthens partner performance proactively manages quality and compliance risks and drives timely resolution of complex Quality issues. This role partners closely with Technical Operations Manufacturing Supply Chain Regulatory Affairs and other Quality functions to ensure effective oversight and management of the external manufacturing network.

Responsibilities:

Lead Quality oversight and governance of CMOs suppliers service providers and alliance partners to ensure compliance product quality and reliable supply
Serve as the primary Quality contact for external partners including issue escalation performance monitoring and relationship management
Lead the development negotiation approval and lifecycle management of Quality agreements
Oversee external change controls deviations investigations and CAPAs ensuring timely resolution and effective Quality risk management
Provide Quality leadership for technology transfers analytical method transfers validation activities and manufacturing readiness
Establish and maintain alliance partner QA governance responsibilities and escalation pathways
Oversee Annual Product Quality Reviews (APQRs) including trend evaluation risk identification and follow-up actions
Provide strategic Quality oversight of analytical and QC activities including method validation and transfer specifications stability programs investigations and contract laboratory performance
Monitor external partner quality metrics identify performance and trends and drive continuous improvement
Support external partner selection qualification audits inspection readiness and regulatory inspections
Identify and communicate product quality compliance and supply risks to senior leadership and drive appropriate mitigation and escalation strategies
Lead develop and mentor the External Operations Quality team to build organizational capability and ensure effective execution of external Quality oversight

Qualifications:

Bachelors degree advanced degree preferred in life sciences engineering pharmacy or related discipline with 15 years of progressive Quality Compliance or related GxP experience within the biotechnology or pharmaceutical industry.
Significant leadership experience in a commercial-stage organization
Demonstrated experience building leading and developing high-performing Quality or Compliance teams
Demonstrated leadership of global or enterprise compliance programs including audits regulatory inspection readiness Quality Risk Management and Quality governance
Strong knowledge of global GxP regulations and expectations including FDA requirements and relevant ICH and international standards
Experience with significant Quality events and escalations recalls/market actions FARs and data-integrity programs
Proven ability to identify and synthesize complex Quality and compliance risks and communicate clear actionable recommendations to senior and executive leadership
Strong executive presence judgment and influencing skills with the ability to maintain independent Quality oversight while building effective cross-functional and external partner partnerships
Experience operating within a commercial biopharmaceutical organization and overseeing compliance across external manufacturers laboratories suppliers and other GxP partners
Demonstrated ability to set strategic direction establish priorities manage resources and lead through organizational and business change
Excellent written verbal analytical organizational and leadership skills
Ability to travel domestically and internationally up to 25%

The anticipated annualized base pay range for this full-time position is $267000 - $327000 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 Companys career site without a valid signed search agreement signed by Companys 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.

Required Experience:

Director

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