QA Validation Manager

Location
Berkeley, CA, US
Posted
Oct 15, 2018
Ref
19-001N
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Overview

This position will primarily be responsible for Quality Assurance oversight of Validation activities, with a focus on IT Computer System Validation and Data Integrity. Additionally, this position will support other Quality Systems processes such as Document Control, Quality Records Management, Training, Deviations and CAPA, Change Control, Complaint handling, and Quality Management Review reporting.

Responsibilities

  • Partner with Information Technologies and other internal customers to provide strategic and technical direction for computerized system validation programs.
  • Review and approve Global Quality Directives, Validation Master Plans, Validation SOPs, and other validation program documents.
  • Review and approve User Requirement Specifications, Validation Plans, Validation Protocols and Reports, Validation Deviations, and other validation execution deliverables.
  • Develop and oversee Data Integrity initiatives including but not limited to data integrity assessments for laboratory, production and utility systems, remediation plans and risk assessments.
  • Support the Quality team during regulatory inspections.
  • Maintain records and generate reports for Quality Management Review (QMR).
  • Provide information for annual product reviews.
  • Maintain a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • This position will involve occasional travel.
  • Other duties as assigned.


Qualifications

  • A BA/BS in engineering, life science or related field and 8+ years' of quality or validation experience in the pharmaceutical industry, or equivalent combination of education and experience. For the Manager level, at least 3 years' management experience is preferred.
  • Knowledge of GAMP5.
  • Knowledge of GMP requirements for biologics or pharmaceuticals and experience with Quality Systems.
  • Strong technical writing and editing skills.
  • Must be an effective communicator with proven abilities to deliver complex information and concepts with clarity.
  • Must possess a flexible approach to problem-solving, be an adept negotiator, and be able to effectively troubleshoot problems and issues.
  • Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team orientation and the ability to work independently.
  • Strong organizational skills with the ability to effectively prioritize, manage multiple projects and tasks, and have great attention to detail.
  • The ideal candidate is highly ethical, flexible, action- and goal-oriented, works well under pressure, and is effective in meeting committed deadlines.
  • The incumbent in this position must be able to remain in a stationary position for periods up to 50%. The person in this role needs to occasionally move about the office for meetings and to access files and other office records/materials.
additional knowledge and skills desired, but not required :
  • Experience with regulatory inspections highly preferred.


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