DescriptionThis is hybrid role with 2-3 days per week onsite in our Waltham, MA officePosition 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.
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
Qualifications:- 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%
The anticipated annualized base pay range for this full-time position is $176,000-$215,000. 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.
Ardelyx also offers a robust benefits package to employees, including a 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, and at least 11 paid holidays.
