Quality Assurance Manager

DescriptionArdelyx 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.Responsibilities:Serve as the primary QA representative supporting day-to-day activities for teams and operations located on the east coastProvide QA oversight for CMC activities supporting development, clinical, and commercial productsEvaluate completed manufacturing documentation (batch records, COAs, packaging records, and related GMP documentation) from CMOs to ensure accuracy, completeness, and complianceReview and approve batch record and product disposition activities in support of clinical trials, process validation, registration activities, and commercial product distributionReview and approve development, qualification, and validation protocols and reportsCollaborate cross-functionally with CMC, Regulatory Affairs, Supply Chain, and external partners to support quality and compliance activities throughout the product lifecycleProvide QA oversight of CMO and suppliers’ activities to ensure required quality standards and regulatory expectations are maintainedGenerate Annual Product Quality Report, quality metrics, management review inputs, and KPI reportingEnsure Quality Agreements clearly define GMP responsibilities, and quality oversight expectations and responsibilities between partiesAssist with inspection readiness activities and support internal and external GMP auditsParticipate in quality systems activities, including deviations, investigations, OOS events, change controls, and related GMP processesIdentify and support continuous improvement opportunities within QA processes and systemsEnsure compliance with cGMP, ICH, FDA, EU, and other applicable regulatory requirementsThis is a hybrid role (2-3 days in office) at our Waltham, MA headquarters.Qualifications: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 processesExperience 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 processesExcellent investigational and QA problem-solving skillsStrong technical writing skillsAdvanced software skills including SharePoint, and VeevaThe anticipated annualized base pay range for this full-time position is $139,000 - $169,000 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.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 Company's career site without a valid, signed search agreement signed by Company's 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.