Manager, Clinical Quality Assurance - Redwood City, CA | Biospace
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Manager, Clinical Quality Assurance

Relypsa Inc.

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Location:
Redwood City, CA
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
483
Salary:
DOE
Required Education:
Other
Areas of Expertise Desired:

Job Description

Company Overview

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.

Product Overview

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.

Position Summary:  

The Manager, Clinical Quality Assurance will be an integral part of the global Clinical Quality Assurance function, supporting the Relypsa teams and the global quality systems. This includes ensuring clinical trials and associated records are in accordance with current Good Clinical Practices and regulatory expectations and the maintenance of the quality management systems, such as SOPs, Training and electronic records management. This position will assist with regulatory inspection readiness, inspection management, and internal audits as well as independently conduct trial related audits. Experience with European regulations and/or in Pharmacovigilance QA is a plus.

Position Responsibilities:

•   Maintain and support CQA Systems: Training, SOPs, Records management
•   Provide support and expertise in GCP/PV related regulatory inspections
•   Maintain GCP compliance for ongoing and planned clinical trials, ensuring data integrity
•   Perform or supervise GCP/PV related internal, vendor and investigator site audits
•   Monitor CAPA execution to ensure accuracy and completeness
•   Represent CQA in assigned projects and cross functional groups
•   Keep CQA management apprised of compliance issues through periodic reports
•   Comply with all signatory limits as communicated by the finance function on behalf of the company.
•   Comply with all Corporate Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.

Requirements

•   Undergraduate degree in life sciences or equivalent experience
•   3 years directly relevant clinical quality assurance experience (GCP)
•   5 years in pharmaceutical industry / CRO
•   Experience with regulatory inspections and inspection readiness (experience with Pharmacovigilance QA is a plus)
•   Experience with quality management electronic systems (SOPs, LMS, e-docs)
•   Fluency in spoken and written English
•   Strong interpersonal, written and oral communication skills
•   Able to build partnerships and diplomatically work with other departments
•   Proficiency in the use of relevant computer systems including MS office.
•   Some travel required (up to 25%)

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.