Executive Director, External Operations Quality

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 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 a 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.

Benefits:

• 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
• at least 11 paid holidays

Ardelyx is an equal opportunity employer.

We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.