Senior Director, GMP, QA, Biological Products

  • Full Time
  • CA
  • Posted 4 months ago

BeiGene

Department: Quality

Reports to (Title): Vice President, Global Quality & Compliance

Type of Contributor: Manager

The Senior Director, GMP QA is responsible for overseeing and coordinating the quality assurance (QA) program. Develops, interprets, and implements quality policies and Quality Systems; facilitates regulatory compliance inspections.  Manages QA compliance activities to support GMP manufacturing, testing and release of biological products under FDA regulations, applicable international regulations, ICH standards, and internal procedures.

Essential Duties & Responsibilities

  • Develop and manage QA program, systems, policies, procedures and controls to ensure BeiGene Biological products conform to established standards and regulatory agency requirements
  • Work with CMO and internal staff to ensure manufacturing processes remain in a compliant state, product meets all required standards and specification
  • Work with CMOs to put Quality Agreements in place, ensure quality standards are met, issues are resolved promptly and effectively
  • Provide expertise in interpretation of global GMP regulations, ICH guidelines and internal policies and procedures
  • Oversee the internal and external audit program, which includes focus on cGMP compliance, regulatory agency inspection readiness and for-cause inspections
  • Recommend systems for audit, write audit plans, coordinate scheduling, conduct and/or manage audit, write audit reports, close audits. Follow up on corrective actions to resolution
  • Ensure proper coordination of strategic business partner audits; mock regulatory inspections, Pre-approval inspection (PAI), and manage regulatory CMO facility inspections
  • Manage documentation, reporting and closure of compliance issues
  • Conduct trend analysis of audit results, investigations, corrective actions, provide management with root cause analysis in annual quality system performance report
  • Review GMP quality metrics. Analyze data relating to manufacturing process controls, and continuous process improvement efforts.  Coordinate the necessary quality adjustments
  • Review relevant GMP documents for compliance to company SOPs, quality systems and regulatory requirements
  • Oversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion
  • Prepare and conduct Quality Management Review meetings
  • Perform and/or direct annual quality system performance review process for GMP related metrics
  • Advise management on external compliance trends impacting company business
  • Manage GMP training initiatives

Core Competencies, Knowledge and Skill Requirements

  • Expert and extensive working knowledge of GMP regulations and experience with regulatory compliance inspections
  • Strong knowledge and experience with 21CFR210, 21CFR211, 21CFR600, as well as international regulations
  • Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems
  • Ability to effectively lead teams and manage staff
  • Must possess strong presentation skills to speak effectively before groups; ability to respond

Communication & Interpersonal Skills

  • Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail

Significant Contacts

  • Interacts with all levels of BeiGene employees; CMOs

DESIRED BACKGROUND AND EXPERIENCE

  • Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Licenses or Certifications: none

REQUIREMENTS:

Education

  • Bachelor of Science degree, in a related scientific discipline

Experience

  • 15+ years of experience in the pharmaceutical/biotechnology industry
  • 10+ years of GMP QA experience, 5 of which includes management experience

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT

  • Must be willing to travel approximately 25%
  • Ability to work on a computer for extended periods of time

To apply for this job email your details to us.careers@beigene.com

Apply using webmail: Gmail / AOL / Yahoo / Outlook