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Senior Quality

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Expert & Leadership (>10 years)

Work from:

Offer summary

B.S./B.A. in scientific discipline, 10+ years of GxP auditing experience, 14+ years in Pharmaceutical/Biotech/Medical Device.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

Requirements:

B.S./B.A. in scientific discipline as a minimum.
Minimum of 10 years of GxP auditing experience in related industry with a significant amount of time spent conducting CSV/SDLC auditing.
Minimum of 14 years of experience within Pharmaceutical / Biotech / Medical Device industry.
Excellent knowledge of GxP regulatory requirements.
Demonstrated success in earning and maintaining a client's confidence through appropriate planning, organizing, controlling, and directing of a project.
Proven record of teamwork, problem solving, project tracking and facilitation of efficient communication between the client and the team.
Experience creating and working with high performance teams.
Quality orientation and high attention to detail.
Demonstrated ability to work with others and drive results.
Ability to think ahead and prepare sound action plans to achieve results.
Audit certification from reputable agency – required
Demonstrated Data Integrity (DI) Expertise – encouraged
Demonstrated Artificial Intelligence (AI) & Machine Learning Experience/Auditing - encouraged
Demonstrated GCP Auditing Experience - preferred

Requirements:

Capacity to make independent sound decisions and independently manage priorities.
Ability to interact in a professional and positive manner with clients and co-workers.
Exceptional communicator with strong persuasion skills and presentations.
Excellent interpersonal and communication skills both written and verbal.
Ability to write concise, accurate reports and other necessary documentation.
Ability to provide and receive constructive feedback.
Ability to organize and manage multiple projects.
Excellent analytical skills and the ability to assess large quantities of information efficiently and effectively.
Ability to read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.