Associate Director, QMS Operations

Ardelyx•Waltham, MA

2d•Hybrid

About The Position

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 hybrid role with 2-3 days per week onsite in our Waltham, MA office Position Summary: The Associate Director, QMS Operations is responsible for strategic oversight, governance, and continuous improvement of key Quality Management System (QMS) processes, with primary accountability for Deviations, Corrective and Preventive Actions (CAPA), Product Complaints and Change Control. This role ensures these processes are compliant, effective, risk-based, and consistently executed across the organization while driving operational excellence and a strong quality culture.

Requirements

Bachelor’s degree, advanced degree preferred, in scientific, engineering, quality, or related discipline with 8 - 10 years of experience in Quality within the pharmaceutical, biotechnology, or other regulated life sciences industry.
Strong expertise in Deviations, CAPA, investigations/root cause analysis, and Product Complaint processes
Demonstrated knowledge of GxP requirements and relevant FDA and global regulatory expectations
Experience serving as a QMS process owner or leading enterprise-level Quality processes and continuous improvement initiatives
Strong analytical, risk-management, problem-solving, and Quality metrics and data analysis capabilities
Demonstrated ability to influence cross-functional stakeholders and drive change without direct authority
Excellent written and verbal communication skills, including experience supporting audits and regulatory inspections
Ability to travel up to 10%

Nice To Haves

advanced degree preferred

Responsibilities

Serve as the enterprise QMS process owner for Deviations, CAPA, and Complaints, and other assigned processes, establishing process standards, governance, and performance expectations
Maintain and continuously improve associated procedures, workflows, systems, and training to ensure effective and consistent process execution
Provide subject matter expertise and oversight for investigations, root cause analysis, CAPA development, and effectiveness checks related to the systems
Monitor process health through KPIs, trends, and Quality data; identify emerging risks and systemic issues and drive corrective actions and process improvements
Partner cross-functionally with Quality, Manufacturing, Supply Chain, Regulatory, Medical, and other stakeholders to ensure timely and effective issue resolution and consistent application of QMS requirements
Ensure QMS processes meet applicable GxP regulations, regulatory commitments, and internal Quality standards
Support regulatory inspections, audits, management reviews, and responses related to Deviations, CAPA, Complaints, Change Control and others as identified
Lead process harmonization and continuous improvement initiatives, including optimization of electronic QMS tools and workflows to improve process effectiveness, compliance, and operational efficiency