Executive Director, QMS & Digital Strategy

Ardelyx, Inc.; Waltham (MA); Hybrid; USD 252,000 - 308,000; Full time

Benefits offered by this job

401(k) match

Parental leave

Organ/bone marrow leave

Equity incentive plans

Health insurance

Life insurance

Disability insurance

Flexible time off

Winter Holiday shutdown

Paid holidays

Job summary

Ardelyx, Inc. is seeking an Executive Director, QMS and Digital, a senior Quality leader responsible for strategy, governance, and continuous improvement of the QMS in a commercial-stage biotech environment.

You will own document control, training, CAPA, change control, quality events, and CSV while leading a team and partnering across the organization to ensure inspection readiness and data-driven decisions.

Qualifications

• Senior leadership for QMS strategy, governance, and compliance.
• Experience in quality systems, document control, training, and CAPA.
• Proven ability to improve quality metrics and enable data-driven decisions.

Responsibilities

• Own the overall QMS strategy, governance, compliance, and improvement.
• Lead core QMS processes: document control, training, CAPA, change control.
• Establish governance with metrics, trends, and management reviews.
• Drive Quality Process Excellence to simplify and standardize processes.
• Develop and execute Quality digital strategy and roadmap with IT partners.
• Own Quality metrics/data infrastructure for actionable insights.
• Oversee CSV and data integrity across Quality systems.
• Lead a high-performing team and partner during inspections/audits.

Skills

QMS governance

Digital strategy

Quality leadership

CAPA & change control

Regulatory inspections

Data analytics

Team building

Process optimization

Tools

CSV validation

Job description

Ardelyx, Inc. is seeking an Executive Director, QMS and Digital, a senior Quality leader responsible for strategy, governance, and continuous improvement of the QMS in a commercial-stage biotech environment.

You will own document control, training, CAPA, change control, quality events, and CSV while leading a team and partnering across the organization to ensure inspection readiness and data-driven decisions.