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 Senior Director of Quality Control will exercise strong leadership skills in managing the operational aspects of drug substance including release and stability. These activities will be conducted internally and with the aide of external laboratories as well as at contract manufacturers. This position will lead the Quality Control Department and provide guidance and development of the Quality Control staff. This position will also manage related budget items.
• Develop, establish and implement quality control processes, specifications, validation, reports, etc. both internally and externally to support Relypsa’s clinical and commercial programs.
• Ensure testing and release services are provided in support of established schedules by being the primary technical and project management liaison with counterparts at the CMOs and contract laboratories for Relypsa.
• Work directly with and provide technical support to operating entities (internal and CMOs) to ensure implementation of testing procedures meet timelines, specifications and remain within budget plans.
• Deliver highly-effective presentations which demonstrate technical expertise and are audience specific.
• Support the Quality Assurance group’s efforts of compliance with the quality systems such as change control, quality investigations, CAPA resolutions in corrective action, audits, and any other recommendations to compliance issues and/or observations as they arise.
• Prepare and review CMC section of regulatory filings for US and EU.
• Represent the quality control perspective for the Pharmaceutical Operations department on cross functional project teams.
• Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and other actions.
PhD degree in Analytical Chemistry or BA/BS or MA/MS with appropriate work experience (generally at least 20+ years of work experience in drug development environment) for both drug substance and drug product analytical operations.
• Experience with all clinical phases and commercial drug substance manufacturing required.
• Prior experience in managing a quality control organization.
• Prior experience related to managing external CMOs on a global basis.
• Working knowledge of pharmaceutical cGMPs (US and EU).
• Must understand standards of practice for the analysis of pharmaceutical products.
• Recent experience in preparation of CMC sections of US or EU regulatory filing is desirable.
• Must have excellent verbal, written, interpersonal, organizational and communication skills.
• Has a demonstrated track record of strong leadership and management skills
• Possesses highly-effective presentation 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.