DescriptionPosition 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 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
This 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 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
The 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.
