Quality Assurance Manager

Ardelyx•Waltham, MA

20d•$139,000 - $169,000•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. Position Summary: The Quality Assurance Manager will serve within Quality Assurance, providing oversight and hands-on support for achieving QA milestones, in a fast-paced pharmaceutical environment. This role will be deeply engaged in day-to-day quality operations, including batch record review, product disposition, investigations, quality agreements, and quality systems support. The position requires strong technical expertise in GMP quality systems, CMC QA, and quality risk management, along with the ability to independently manage complex quality activities and partner cross-functionally across the organization. In addition to core operational responsibilities, this individual will serve as the primary QA representative supporting operations on the East Coast and provide occasional back-up support to department management to help ensure continuity when coverage is needed.

Requirements

Bachelor’s degree in science or related field with 10+ years of progressive GxP Quality Assurance experience within biotechnology or equivalent experience.
Experience in relevant CMC area (DS, DP), with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes
Experience in a manufacturing setting as a Quality person in the plant (QA PIP)
Extensive knowledge of GMP regulations and guidance (such as FDA, EU, and ICH)
Experience with Quality Assurance systems and processes
Excellent investigational and QA problem-solving skills
Strong technical writing skills
Advanced software skills including SharePoint, and Veeva

Responsibilities

Serve as the primary QA representative supporting day-to-day activities for teams and operations located on the east coast
Provide QA oversight for CMC activities supporting development, clinical, and commercial products
Evaluate completed manufacturing documentation (batch records, COAs, packaging records, and related GMP documentation) from CMOs to ensure accuracy, completeness, and compliance
Review and approve batch record and product disposition activities in support of clinical trials, process validation, registration activities, and commercial product distribution
Review and approve development, qualification, and validation protocols and reports
Collaborate cross-functionally with CMC, Regulatory Affairs, Supply Chain, and external partners to support quality and compliance activities throughout the product lifecycle
Provide QA oversight of CMO and suppliers’ activities to ensure required quality standards and regulatory expectations are maintained
Generate Annual Product Quality Report, quality metrics, management review inputs, and KPI reporting
Ensure Quality Agreements clearly define GMP responsibilities, and quality oversight expectations and responsibilities between parties
Assist with inspection readiness activities and support internal and external GMP audits
Participate in quality systems activities, including deviations, investigations, OOS events, change controls, and related GMP processes
Identify and support continuous improvement opportunities within QA processes and systems
Ensure compliance with cGMP, ICH, FDA, EU, and other applicable regulatory requirements