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 Manager of Quality Assurance will report to the Associate Director or Director, Quality Assurance. This position will manage the quality aspects of clinical and commercial drug substance manufacturing, validation, and analytical testing at contract manufacturers and product release. This position will also manage Relypsa’s internal Quality Systems specific to a vendor (deviation, change control, etc).
• Establish assigned internal SOPs applicable to internal functions as well as outsourced functions.
• Provide QA support in the development, establishment and maintenance of drug substance validation and manufacturing of commercial drug substance at CMOs.
• Provide QA support in the development, establishment and maintenance of drug substance analytical methods (validation and transfer) at CMOs.
• Establish and ensure that policies at CMOs adhere to cGMPs and regulatory requirements of FDA, EMA and other regulatory agencies, as required.
• Oversee QA Review of process validation protocols, validation data and validation reports, master batch records, executed batch records from CMOs or Relypsa drug substance as assigned. Work with internal and CMO entities to resolve review comments to acceptance by both Relypsa QA and CMO.
• Work directly with operating entities (internal and CMOs) to ensure that clinical and commercial drug substance meet all required quality standards and specifications.
• Provide quality assurance support in the technology transfer, scale-up and validation of drug substance manufacturing at CMOs.
• Establish and ensure CMOs achieve the appropriate levels of compliance and develop plans to ensure on-going performance is maintained.
• Provide effective QA support for the manufacturing and disposition of clinical and commercial lots.
• Ensure compliance with the quality systems such as change control, quality investigations, and CAPA resolutions. Management of assigned QA operation tasks in accordance to SOPs (e.g., trending report, training program).
• Review and approve the Production Records, Specifications, Test Methods, Validation Protocols and Stability Protocols.
• Facilitate resolution of quality issues in a timely manner. Coordinates communication with contract manufacturers and internal cross functional teams for quality issues.
• Prepare, review and approve CMC sections of regulatory filings as assigned.
• Plan, schedule and perform QA in plant support and audits/inspections (internal and external) as assigned.
• Monitor and provide corrective action recommendations to compliance issues and/or observations as they arise.
• Training of personnel and provide GXP training as required
• Represent the quality assurance department on cross functional project teams.
• BA or BS degree in a scientific discipline preferred, or comparable experience.
• At least 8 years of experience in cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment.
• Experience with Phase 3 and / or commercial drug substance/drug substance manufacturing is required.
• Prior experience related to quality systems in technology transfer, scale up and validation.
• In-depth knowledge of pharmaceutical cGMPs (US and EU).
• Must understand standards of practice for the manufacture of solid dosage form.
• 3-5 years of management experience.
• Recent experience in reviewing of CMC sections of US or EU regulatory filing is required.
• Must have excellent verbal, written, interpersonal, and 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, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.