Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a non-absorbed potassium binder, which is being developed for the treatment of hyperkalemia. The company was formed in 2007 and is based in Redwood City, CA. More information is available at www.relypsa.com.
Patiromer (RLY5016) for Oral Suspension is a high capacity non-absorbed oral potassium binder being developed for the management of elevated serum potassium levels. Relypsa completed the Phase 3 clinical program in 2013.
The 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/drug product manufacturing at contract manufacturers and product release. This position will also manage Relypsa’s internal Quality Systems
• Assist in the development, establishment and maintenance of internal quality assurance systems, processes and procedures as the company moves through different phases of drug development and towards commercialization
• Establish assigned internal SOPs applicable to internal functions as well as outsourced functions
• Establish and ensure that policies at CMOs adhere to cGMPs and regulatory requirements of FDA, EMA and other regulatory agencies, as required
• Work directly with operating entities (internal and CMOs) to ensure that clinical and commercial drug products meet all required quality standards and specifications
• Provide quality assurance support in the technology transfer, scale-up and validation of drug product 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 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
• Represent the quality assurance department on cross functional project teams
• BA or BS degree in a scientific discipline
• At least 5 years’ experience in Quality Assurance at an operational level supporting manufacturing in a pharmaceutical or biotech environment. Minimum of 2 years in outsourced manufacturing environment
• Experience with Phase 3 and/or commercial drug product manufacturing is desirable
• 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
• 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
• Position requires 5-10% 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 and stock options reflect Relypsa’s high regard for our employees.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Relypsa, Inc. is an EOE