Manager / Director of Quality Assurance

4 days ago

Pleasanton, United States Crystal Pharmatech Full time
Job DescriptionJob Description

Role Description

Reporting directly to the CSO, the Director of Quality Assurance (QA) is responsible for establishing and administering quality systems supporting compliant nonclinical laboratory study Good Laboratory Practice (GLP) and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies Good Clinical Laboratory Practice (GCLP). Assure Test Site Management (TSM) that facilities, equipment, personnel, methods, practices, records, and controls are in conformance of regulations.

 

Key Responsibilities

  • Host client and regulatory inspections including preparing responses of findings thereof.
  • Supports organization regulatory professionals across BABM sites.
  • Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance.
  • Establish and maintain a state of inspection readiness including site specific folders.
  • Establish company compliance of GLP and GCLP and GCPs for FDA and applicable international regulations.
  • Establish and administer a company Master Schedule.
  • Establish and administer QA Standard Operating Procedures (SOP’s), QA Files, and QA Audit Log.
  • Assure QA department inspection reports and any other supporting documentation or required records are processed and archived, as appropriate.
  • Monitor regulatory landscape and interpret regulatory requirements for application to business processes and procedures.
  • Authors and/or review Standard Operating Procedures (SOPs) and Statistical Analysis Plans (SAP).
  • Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance.
  • Provide GLP and GCLP training.
  • Recruits, develops, manages, and mentors regulatory professionals and helps create a supportive and growth-minded culture.
  • Plan, conduct and report inspections of the internal facilities to TSM.
  • Plan, conduct and report audits of external vendors to assess compliance with regulations, industry standards, and best practices.
  • Establish and administer a company Risk Register.
  • Identify regulatory compliance issues and provide regulatory support to departments.
  • Provide TSM with monthly status reports the company's compliance with GLP and GCLP regulations including problems and corrective action.
  • Represent QA in company meetings.

 

Qualifications and Educational Requirements

  • BA/BS degree in biological/physical sciences required. Advanced degrees (MA, PhD) preferred.
  • 10+ years relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/ pharmaceutical industry or a combination of education and experience.
  • Able to provide regulatory leadership and guidance on cross-functional teams and work in a matrixed environment.
  • A business leader, capable of strategic thinking, planning, and proposing innovative solutions to regulatory challenges.

How to Apply

CV can be emailed directly to career_us@crystalpharmatech.com. Please be sure to denote the Job Title of the position you are applying.

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