Associate Director, QMS Operations

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.

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:

• Bachelors 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 $176000-$215000. 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.

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 Companys career site without a valid signed search agreement signed by Companys 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.