Senior Director of Quality Assurance for Clinical Trial Materials and Centralized Services

4 weeks ago


Indianapolis, Indiana, United States BioSpace, Inc. Full time
Job Title: Senior Director of Quality Assurance for Clinical Trial Materials and Centralized Services

At BioSpace, Inc., we are committed to delivering high-quality products and services to our customers. We are seeking a highly experienced and skilled Senior Director of Quality Assurance for Clinical Trial Materials and Centralized Services to join our team.

Main Responsibilities:
  • Lead the quality assurance team responsible for ensuring compliance with regulatory requirements and industry standards for clinical trial materials and centralized services.
  • Develop and implement quality systems and processes to ensure the delivery of high-quality products and services.
  • Collaborate with cross-functional teams to identify and mitigate quality risks.
  • Ensure compliance with regulatory requirements and industry standards for clinical trial materials and centralized services.
  • Develop and implement training programs for quality assurance personnel.
Requirements:
  • BS, MS or PhD in Pharmacy, Engineering, or Physical Sciences (or equivalent experience).
  • At least 10 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).
  • Past leadership experience.
  • Demonstrated problem-solving skills and a broad knowledge of quality systems and global quality standards.
  • An understanding of regulatory agency requirements such as the FDA, EMEA, ICH, particularly in cGMPs.
  • Demonstrated solid judgment and initiative.
  • Previous experience working effectively with external partners.
  • Proficient in data visualization/analysis.
Additional Information:

BioSpace, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We are committed to creating a diverse and inclusive work environment and welcome applications from qualified candidates from all backgrounds.


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