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Sr. Manager, Quality Systems and Compliance

Company: Rani Therapeutics
Location: San Jose
Posted on: September 22, 2022

Job Description:

Sr. Manager, Quality Systems and Compliance This position is responsible for maintaining and improve compliance to applicable regulatory requirements by maintaining an effective quality management system. The ideal candidate will be primarily responsible for the continuous improvement of Rani quality systems for record management, change control, training, auditing, supplier management, inspection readiness, quality metrics tracking and reporting. This individual works closely with all different functions/departments at Rani to ensure adherence to Rani policies as well as to applicable regulatory requirements. - Requirements

  • Maintain and improve the quality system and provide compliance oversight per FDA 21 CFR part 820, 210, 211, 4 and ISO 13485 requirement
  • Oversee and maintain the deviation, CAPA, change control, training, product complain, investigation and non-conformance programs to ensure compliance with internal SOP and regulatory authority requirements
  • Create and establish the annual internal audit program
  • Trend and report quality metrics for Management Reviews. Implement appropriate enhancements
  • Ensures that performance and quality of products conform to established standards and regulatory agency requirements
  • Review regulatory requirements documents and provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance
  • Implement quality system changes to support evolving regulations and international standards
  • Participate in regulatory authority inspections
  • Lead/coordinate investigations, and the development and implementation of corrective and preventative action (CAPA)
  • Work extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis
  • Manage and trend product complaints
  • Manage supplier qualification program and establish supplier qualification processes, audit plans, quality agreements, quality performance metrics and perform GMP audits to suppliers and service providers
  • Support the organization in maintaining a work environment focused on quality that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • Ensure an understanding of the external regulatory requirements, in order to adapt product quality strategy accordingly -Qualifications
    • Attention to detail and organizational skills
    • Good interpersonal and communication skills
    • Ability to work as a part of a team
    • Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges
    • Flexible and adaptable to changing environment and priorities -Education and/or Job Experience
      • 10+ years of relevant experience in the pharmaceutical or biotechnology industry, and a Bachelor's degree in science or related fields
      • Strong knowledge of cGMP requirements including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO)
      • Experience with Quality System Regulation 21 CFR 820 and ISO 13485:2016 Quality Management System
      • Previous experience with combination products is required
      • Must be familiar with: cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLP
      • Strong knowledge of medical devices, combination products and general pharmaceutical manufacturing
      • Strong project management and process improvement skills
      • Demonstrate keen understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
      • Experience with Risk Management principles according to ISO 14971
      • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organization
      • Must demonstrate ability to work independently, make effective decisions - Rani Therapeutics LLC is an equal opportunity employer. This means that Rani Therapeutics LLC is dedicated to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, military status, sexual orientation, or any other status protected by federal, state or local law. Any notes applied to candidates are subject to review for Equal Employment Opportunity hiring policies.

Keywords: Rani Therapeutics, San Jose , Sr. Manager, Quality Systems and Compliance, Executive , San Jose, California

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