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Head of Quality Assurance

2 months ago


Fishers, Indiana, United States INCOG BioPharma Services Full time

Quality Assurance Executive

INCOG BioPharma Services is seeking a dedicated Quality Assurance Executive who possesses a strong commitment to guiding teams and enhancing processes. This role is crucial for the advancement of innovative therapeutic solutions within a reputable organization.

Key Responsibilities

  • Direct the strategic vision and operational management of the QA division to guarantee adherence to international health authority standards and internal protocols.
  • Supervise the activities related to production, packaging, and quality assessment.
  • Evaluate and authorize master batch records, deviations, and corrective and preventive actions (CAPAs).

Qualifications

  • Bachelor's degree in a scientific discipline.
  • A minimum of 15 years of experience in the biopharmaceutical sector, including at least 5 years in Quality Assurance within sterile manufacturing environments.
  • Proven experience in coaching managerial personnel and executing regulatory compliance initiatives.
  • Strong skills in leadership, effective communication, project oversight, and financial management.
  • Prior experience with audits and regulatory inspections.
  • Expertise in automated data management platforms.

We welcome discussions regarding your qualifications and potential fit for this position, even if you do not meet every requirement.

About INCOG BioPharma Services:

Our organization is committed to fostering Equality and Diversity in the workplace, ensuring a fair and inclusive environment for all employees.