Description

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 company's 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:

• Bachelor's 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 $267,000 - $327,000 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.