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Quality Assurance Head

Quality Assurance Head

About us

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.

We are excited for our next QA Head to join the Viralgen team!

About the role

We are seeking a QA Head who will play a key role for our new Commercial Plant within the Quality Assurance department.

The job involves stablishing and maintaining commercial QA area with the assistance of Quality Director.

Responsibilities

  • Directs and oversees the quality assurance department and supervisory staff.
  • Continuous improvement of Key Quality Indicators of company.
  • Lead inspections from regulatory agencies and customer related audits.
  • Evaluate production operations from a strategic level to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
  • Collaborate with management and senior staff across production departments and roles to define acceptable quality standards.
  • Participate actively in the digitalization roadmap of company.
  • Develops and implements quality standard operating procedures.
  • Collaborate in daily activities of department such as Quality Agreements creation, deviation and change management, vendors programs etc.
  • Interact with regulatory agencies during inspections.
  • Collaborates with customers during product lifecycle.
  • Conducts inspections and quality control checks.

About you

  • Bachelor’s degree in Biochemistry, Biology, Chemistry, Pharmacy or related industrial, scientific, or business field.
  • Quality Assurance expertise and extensive knowledge on revision of GMP documentation. Knowledge on electronic systems such as LIMS, Trackwise and SAP will be an asset.
  • 5 years of related experience in pharma industry leading quality teams.

Desired competencies

  • Fluent in English and in Spanish.
  • Ability to multi-task and meet deadlines in a fast-paced environment
  • Demonstrated ability to work both independently and in a team environment.
  • Demonstrated passion for producing high-quality work.
  • Proactive management and positive attitude to change and challenges.
  • Communication skills and self-management.