Employer requires a Bachelors degree in a scientific or engineering field and at least seven 7 years of progressively more responsible work experience in a GMP related field within a biotechnology or biologics manufacturing facility.br br Alternatively, employer is willing to accept at least a Masters degree in a scientific or engineering field and at least five 5 years of progressively more responsible work experience in a GMPrelated field within a biotechnology or biologics manufacturing facility.br br In addition, the employer requires the followingbr br 1 Demonstrated ability managing and leading Quality Systems teams or associated teams at a department or company level gained through at least five 5 years of work experience in a team lead role or management of projects while working with multidisciplinary teams;br 2 Demonstrated knowledge of global quality systems and regulatory requirements 21 CFR Part 11210211820, ISO 13485, PAL gained through at least five 5 years of work experience;br 3 Demonstrated ability with FDA or Notified Body inspections gained through at least five 5 years of work experience; andbr 4 Demonstrated knowledge of GMP, SOPs, and quality systems gained through at least five 5 years of work experience.br br All years of experience may be gained concurrently.br br Travel Requirement 10 domestic travel per year; 15 international travel per year. Beneficiary is willing to meet the travel requirement.
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