Associate Director, Quality Assurance Process and Analytical Validation - FM10


Full-time

Menlo Park, California, United States

Quality Assurance

Location: Menlo Park, CA

Reporting to: Senior Vice President of Global Quality Assurance and GxP Compliance

Job summary

Reporting to the Senior Vice President of Global Quality Assurance and GxP Compliance, the role will lead the continued build-out of the Orchard Therapeutics Process and Analytical Validation Program. The role will oversee the development of robust systems to support qualification and validation efforts of facilities, equipment, cleaning validation, methods, and processes.

Expertise in FDA, Eudralex, GAMP, ICH, and industry best practices is a must. This is an exciting opportunity to shape the future of the Orchard organization by leading and building the QA Validation function.

Key Elements and Responsibilities

  • Maintain the Orchard Process and Analytical Validation systems including establishment and/or refinement of policy, procedures, and work instructions.
  • Design and maintain a robust Facility, Utility, and Equipment Qualification Program.
  • Consult on Process and Cleaning Validation strategies.
  • Draft, review, and approve various Validation related documents (including master plans, requirements documents, protocols, and reports).
  • Support analytical vendor qualification and auditing
  • Utilize expertise to educate organization on Process and Analytical Validation Best Practices.
  • Support validation activities at CDMOs as needed.
  • Provide Quality Assurance validation support to Technical Operations Organization
  • Quality Assurance approval authority of change controls and process and analytical validation documents assessing Impact Assessment, Action Plans, and Risk Assessment.
  • Quality Assurance approver on CSV documentation.

Requirements

Required knowledge

  • 10+ years of experience in a GXP environment and 5+ years working in the area of Process and Analytical Validation.
  • 3+ years of management experience.
  • Experience in the pharmaceutical, biotechnology, or gene therapy industry.
  • Travel up to 20%
  • Expert Knowledge of IQ/OQ/PQ
  • Expert best practices for aseptic practices and contamination control
  • Experience leading Equipment Qualification Program
  • Experience in Cleaning Validation
  • Experience with Process Validation and Continuous Process Verification
  • Experience building and leading a team
  • Conversant in GAMP best practices
  • Experience in GXP Environment
  • Experience with vendor audits
  • Experience with facility design, commissioning, qualification, and start-up is a plus
  • Ability to communicate well across different disciplines and experience levels.
  • Experience supporting regulatory inspections
  • Experience using risk management tools (FMEA, etc.)

Skills & Abilities

  • Expert Knowledge of IQ/OQ/PQ
  • Expert best practices for aseptic practices and contamination control
  • Experience leading Equipment Qualification Program
  • Experience in Cleaning Validation
  • Experience with Process Validation and Continuous Process Verification
  • Experience building and leading a team
  • Conversant in GAMP best practices
  • Experience in GXP Environment
  • Experience with vendor audits
  • Experience with facility design, commissioning, qualification, and start-up is a plus
  • Ability to communicate well across different disciplines and experience levels.
  • Experience supporting regulatory inspections
  • Experience using risk management tools (FMEA, etc.)

Education

  • Bachelor’s Degree in a technical discipline (Engineering, Chemistry/Biology).

Benefits

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify