Executive Director, External Quality & Manufacturing Oversight

Ardelyx, Inc.; Waltham (MA); Hybrid; USD 267,000 - 327,000; Full time

Benefits offered by this job

401(k) match

Parental leave

Living organ & bone marrow leave

Equity incentive plans

Health plans (medical, prescription)

Life insurance

Disability

Flexible time off

Winter holiday shutdown

Paid holidays

Job summary

Ardelyx, Inc. in the United States (Waltham, MA) seeks an Executive Director, External Operations Quality to provide strategic leadership for quality oversight across the external manufacturing network. You will govern CMOs, labs, and suppliers, manage quality agreements, and drive CAPAs, regulatory readiness, and continuous improvement.

Oversight extends to tech transfers and analytical method validation. This senior role partners with Manufacturing, Regulatory, and Supply Chain, requiring 15+

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%

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

Skills

Leadership experience

Executive presence

Communication skills

Analytical skills

Judgment and influencing

Cross-functional collaboration

Education

Bachelor’s degree, advanced degree preferred

Job description

Ardelyx, Inc. in the United States (Waltham, MA) seeks an Executive Director, External Operations Quality to provide strategic leadership for quality oversight across the external manufacturing network. You will govern CMOs, labs, and suppliers, manage quality agreements, and drive CAPAs, regulatory readiness, and continuous improvement.

Oversight extends to tech transfers and analytical method validation. This senior role partners with Manufacturing, Regulatory, and Supply Chain, requiring 15+