Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company. More information is available at www.relypsa.com.
Veltassa® (patiromer) for oral suspension was approved in October 2015 for the treatment of hyperkalemia, a condition defined as elevated blood potassium levels that can cause abnormal heart rhythms and even sudden death. A potassium binder, Veltassa® is the first new medicine for the treatment of hyperkalemia in more than 50 years and is the first commercialized medicine resulting from Relypsa’s polymer technology platform. Relypsa is committed to ensuring that people living with the burden of hyperkalemia have access to Veltassa®.
The Associate Director of QA Systems and Compliance will report to the Director of QA Systems and Compliance. This position will be responsible for implementing and managing Quality Systems with an emphasis on Electronic Quality Management Systems (EQMS). This position will also manage the Document Control function, the Change Management Program and the cGMP Training Program.
• Develop, establish and maintain compliant quality assurance systems, processes and procedures in support of commercial products.
• Manage projects to validate and implement Electronic Quality Management Systems (EQMS).
• Create compliant SOPs applicable to internal functions and outsourced functions as needed.
• Ensure that internal policies and procedures for management of commercial products adhere to cGMPs and the requirements of FDA, EMA and other regulatory agencies.
• Develop, track and regularly report metrics around key performance indicators (KPIs).
• Ensure compliance with major quality systems such as change control, quality investigations and CAPA resolutions.
• Facilitate resolution of quality issues in a timely manner. Coordinate communication with internal cross functional teams for quality issues.
• Prepare, review and approve CMC sections of regulatory filings.
• Perform audits of vendors and Contract Service Providers as needed.
• Manage the cGMP training program and provide training as needed.
• Manage the Document Control function.
• Monitor and provide corrective action recommendations to compliance issues and/or observations as they arise.
• Represent the quality assurance department on cross functional project teams.
• BA or BS degree in a scientific discipline or equivalent experience.
• At least 12 years’ experience in Quality Assurance at an operational level supporting quality systems and compliance in a pharmaceutical or biotech environment.
• Minimum of 3 years’ experience working in an outsourced commercial manufacturing environment.
• Prior experience managing computer system validation projectss
• In-depth knowledge of pharmaceutical cGMPs (US and EU).
• Must understand standards of practice for the manufacture of solid dosage forms.
• Experience preparing CMC sections of US or EU regulatory filings desirable.
• Must have excellent verbal, written, interpersonal, organizational and communication skills.
• Position requires 10-15% travel.
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Relypsa’s high regard for our employees.
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.