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Associate Director, QA - Computer Systems Validation

Reference Number: 3146
Location: MA

Our client is a rapidly growing, specialty biopharmaceutical company.  They have asked us to assist them in their search for an Associate Director, Quality Compliance and Audit - Computer Systems Validation.

Major tasks and responsibilities will include: 

  • Ensures that computerized systems used for regional and global GxP regulated activities adhere to applicable FDA, EMA, ICH, and MHLW regulations and guidance, SOPs and industry best practices for electronic records and electronic signatures and computerized system validation through QA review of validation documentation, audits and periodic system reviews.
  • Performs QA review of regional and global validation documentation including change controls in accordance with applicable regulations/guidance, SOPs and industry standards using a risk based approach.
  • Performs 21 CFR Part 11 audits of internal computerized systems, GXP suppliers, computer software suppliers and hosted data centers.
  • Supports CSV project teams from a QA perspective.
  • Participates in global committees and activities.
  • Manages 21 CFR Part 11 audit schedule and associated activities for GxP regulated systems to ensure all systems used for the company’s GxP activities are maintained in a validated state and the validation documentation is adequate for regulatory inspection.
  • Supports continuous improvement of QA methods and procedures including development and review of regional and global SOPs and Guidance Documents.
  • Reviews system inventory and validation schedule; maintains CAPA program for incident evaluation, tracking and reporting of system related investigations, perform trending analysis.
  • Provides support for all the company’s audits and inspections by business partners and regulatory agencies.
  • Elevates critical and significant quality assurance and compliance issues to senior management.
  • Knowledgeable of GXP regulations.

 We seek candidates with the following qualifications:

  • A Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.
  • A minimum of 8 years of experience in an FDA regulated biotechnology, pharmaceutical or medical device company with quality assurance experience auditing and reviewing validation activities for clinical, safety, laboratory and manufacturing computerized systems.
  • Good understanding of FDA/EU Regulatory Requirements and industry best practices for computerized system validation and electronic records and electronic signatures.
  • Understands lifecycle approach and risk based approach to validation.
  • Position may require approximately 25-30% travel.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3146. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.