Senior Director, External Quality Operations

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

Benefits offered by this job

401(k) match

Equity awards

Paid parental leave

Job summary

Ardelyx, Inc. is seeking an Executive Director, External Operations Quality to provide strategic leadership for quality oversight of the company’s external manufacturing network, including CMOs, packaging, and testing partners.

You will partner with Technical Operations, Regulatory Affairs, and Supply Chain to ensure products meet quality standards, regulatory requirements, and supply commitments across the global network.

Qualifications

• Bachelor’s degree in life sciences or related, 15+ years in quality/compliance in biotech/pharma.
• Proven leadership in a commercial-stage organization and building high-performing QA teams.
• Experience with global regulatory expectations and audits.
• Travel up to 25% domestically and internationally.

Responsibilities

• Oversee external manufacturing QA governance and supply quality.
• Lead quality agreements lifecycle, deviations, CAPAs, and supplier audits.
• Provide strategic QA oversight of tech transfers, validation, and readiness.
• Coach and develop the External Operations Quality team.

Skills

Leadership

Quality oversight

GxP knowledge

Regulatory compliance

Executive communication

Cross-functional collaboration

Risk management

External manufacturing oversight

Education

Bachelor's degree

Advanced degree preferred

Tools

Quality management systems

Job description

Ardelyx, Inc. is seeking an Executive Director, External Operations Quality to provide strategic leadership for quality oversight of the company’s external manufacturing network, including CMOs, packaging, and testing partners.

You will partner with Technical Operations, Regulatory Affairs, and Supply Chain to ensure products meet quality standards, regulatory requirements, and supply commitments across the global network.