Executive Director, External Operations Quality

Ardelyx•Waltham, MA

3d•Hybrid

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. 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.

Requirements

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%

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