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Associate Director/Director of Quality Control

Relypsa Inc.

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Location: Redwood City, CA Posted Date: 4/8/2013 Position Type: Full time Job Code: HR003 Required Education: High school or equivalent Areas of Expertise Desired: Quality Control

Description

Relypsa is seeking a reliable, self-motivated professional for the position of Associate Director/Director of Quality Control to lead the company’s QC efforts.   This position will be responsible for all quality control activities for Relypsa while working collaboratively with CMOs and contract testing laboratories that manufacture and test Relypsa products.    He/she will develop and establish internal processes and procedures for the QC function as the company moves from Phase 3 to commercialization.  
RESPONSIBILITIES:
•   Work directly with operating entities (internal and CMOs) to coordinate the testing of release and stability samples according to cGMPs
•   Manage the review of data generated at contract laboratories
•   Work collaboratively with CMOs to achieve the appropriate levels of compliance (conducting and closing investigations, deviation investigations, change controls, trend analysis, etc.)
•   Manage stability protocols, reports and review of the stability raw data  
•   Manage the investigation of out of specification results by participating in the planning, execution, and report writing process of investigations initiated internally or by vendors
•   Prepare and implement change control for analytical methods, protocols, and specifications
•   Write, review and approve SOPs, test methods, specifications, protocols, reports, shipment of samples and other documentation related to QC and analytical testing
•   Prepare stability sections for regulatory/QC documents in support of regulatory fillings including the NDA, annual product reviews, annual stability reports and annual reports
•   Present data at group meetings and provide improvement suggestions based on data
•   Represent the Quality Control department on cross functional project teams  

Requirements

•   Minimum of a BA or BS degree in a scientific discipline.  At least 7 years of experience in Quality Control at an operational level and 3 years in a management level supporting manufacturing in a pharmaceutical or biotech environment.  Minimum of 3 years in outsourced manufacturing environment  
•   Strong technical and working knowledge of development and IND/NDA requirements for both pharmaceutical APIs as well as finished dosage forms
•   Experience with Phase 3 and commercial drug product manufacturing required.
•   In-depth knowledge of pharmaceutical cGMPs (US and EU)
•   Must understand standards of practice for the manufacture of solid dosage form
•   Superior communication (both written and verbal), interpersonal, and organizational skills are essential
•   Experience working in a multi-cultural, multi-lingual environment with a demonstrated ability to contribute successfully in a multi-disciplinary team environment
•   Must have experience in managing diverse project activities independently and through managers
•   Recent experience in preparation of CMC sections of US or EU regulatory filing would be a plus
•   Position requires 5-10% travel
NOTE: This job description is not intended to be all-inclusive.  Other related duties as negotiated may be assigned to meet the ongoing needs of the organization.

As an employee of Relypsa, you will actively contribute to the development of potential new products. Our small company culture provides opportunity 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 including pre-IPO stock options reflect Relypsa’s high regard for our employees. EOE
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