Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
The QA Specialist III will administer QA ongoing projects for Quality Operations. Working in a fast-paced pharmaceutical environment with a broad scope of responsibilities, this position will bring many different skills to the job, with a focus on achieving QA milestones. This role will ensure manufacturing or processes adhere to compliance or industry standards by possessing strong document, quality risk assessment management, and CMC QA skills, in a GxP environment. This will be a hybrid position based out of the Newark, CA office.
Responsibilities:
- Perform batch record review and product disposition in support of clinical trials, registration, validation, and commercial product distribution
- Evaluate compliance of completed manufacturing records (batch records, COC/ COA, packaging, and any related data as applicable) from CMO as necessary to ensure accuracy and completeness
- Collaborate with CMC to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process
- Review development, and validation protocols and reports
- Participate in ensuring compliance with quality systems, internal SOPs, deviations, OOS, product complaints, CAPAs, change controls-related processes and regulatory requirements
- Provide QA CMO oversight activities to ensure required quality standards are maintained
- Retrieve data to support the reporting of Quality metrics on a quarterly basis in support of Management reviews and KPIs
- Assist with various quality risk management frameworks, including Annual Product Quality Report preparation
- Support cGMP compliance audits of internal and GMP suppliers’ quality systems
- Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings
- Perform other related duties as assigned from time to time-based on company needs
This is a hybrid role based out of our Newark, CA office and will require a presence in this office.
Qualifications:
- Bachelor’s degree in science or equivalent relevant experience with 5+ years of combined GxP experience in process development and commercial in biotechnology or pharmaceutical industries 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)
- Working knowledge and/or understanding of quality risk assessment management principles
- 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
- Demonstrate ability to deal with frequent changes, delays, or unexpected events
- Strong technical writing skills
- Advanced software skills including SharePoint, and Veeva
- Proven ability to work independently and under tight deadlines and pressure in a composed manner
- Effective interpersonal and communication skills, and teamwork oriented
- Comfortable communicating with all levels of staff, including executives
The anticipated annualized base pay range for this full-time position is $113,000-$129,000. 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.
