Senior Director, External Quality Operations

Ardelyx; Newark (CA); Hybrid; USD 267,000 - 327,000; Full time

Benefits offered by this job

401(k) match

Parental leave 12 weeks

Organs & marrow leave up to 12 weeks

Equity incentives

Health plans

Life & disability insurance

Flexible time off

Holiday shutdown

Paid holidays

Job summary

Ardelyx is seeking an Executive Director, External Operations Quality to lead quality oversight of the external manufacturing network, including CMOs, labs, and suppliers. You will establish governance, drive risk management, and partner with Technical Operations, Manufacturing, and Regulatory Affairs to ensure compliance and reliable supply.

This senior role requires managing quality events, CAPAs, and tech transfers, while guiding the QA team and collaborating with executive leadership across

Qualifications

• Bachelor's degree with 15+ years of progressive Quality/Compliance or related GxP experience in biotech/pharma.
• Significant leadership experience in a commercial-stage organization.
• Experience building and developing high-performing Quality/Compliance teams.
• Leadership of global compliance programs including audits and regulatory readiness.
• Strong knowledge of global GxP regulations and FDA/ICH expectations.
• Experience with quality events, recalls, FARs, and data-integrity programs.
• Ability to identify and synthesize risks and present actionable recommendations to executives.
• Executive presence with influence across cross-functional and external partner teams.
• Experience in a commercial biopharma environment overseeing external manufacturers and labs.
• Proven ability to set strategic direction and manage resources through 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 partners.
• Serve as primary Quality contact for external partners and manage escalations.
• Negotiate, approve, and lifecycle manage Quality agreements.
• Oversee external deviations, CAPAs, investigations, and risk management.
• Provide Quality leadership for technology transfers and manufacturing readiness.
• Establish alliance partner QA governance and escalation paths.
• Oversee APQRs, trend evaluation, risk ID, and follow-up actions.
• Oversee analytical/QC activities including method validation and transfer.
• Monitor partner quality metrics and drive continuous improvement.
• Support partner qualification, audits, and regulatory inspections.
• Communicate product quality and supply risks to senior leadership and drive mitigation.
• Lead and mentor the External Operations Quality team.

Skills

Leadership

Executive presence

GxP knowledge

Regulatory compliance

Education

Bachelor's degree, 15+ years in life sciences/engineering/pharmacy

Job description

Ardelyx is seeking an Executive Director, External Operations Quality to lead quality oversight of the external manufacturing network, including CMOs, labs, and suppliers. You will establish governance, drive risk management, and partner with Technical Operations, Manufacturing, and Regulatory Affairs to ensure compliance and reliable supply.

This senior role requires managing quality events, CAPAs, and tech transfers, while guiding the QA team and collaborating with executive leadership across