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Director of Quality - Topeka, United States - ACE Partners
Description
Director of QualityLocation :
KansasSalary : $150,000 - $200,000
PTO :
13 daysRelocation :
SupportResponsibilities:Lead large programs and departments to ensure product quality and compliance with regulations and company policies.
Develop and deploy quality systems to ensure products meet defined requirements.
Drive continuous improvement initiatives to enhance quality, reliability, and cost-effectiveness.
Collaborate across functions and franchises to achieve objectives.
Manage customer and regulator interactions regarding product quality and processes.
Oversee adherence to specifications and procedures for product quality.
Coach, train, and develop the team.
Qualifications:
Deep knowledge of FDA regulatory environment for pharmaceuticalsExperience in Production Quality, Change Management, Supplier Quality, Non-Conformance investigations, Complaint management, and Document Control.
Excellent communication and interpersonal skills.
Extensive working knowledge of quality and regulatory standards and regulations.
Bachelor's degree in Chemistry, Microbiology, Engineering, or related field.
Minimum 10 years of experience in Pharma Industry.
Minimum 5 years of Quality Management experience in the FDA Pharma Industry.
Preferred
Qualifications:
Advanced degree or MBA.Experience with contract manufacturing and remediation of Quality systems in FDA 483 or Warning Letter environment.
Six Sigma, Lean Manufacturing, or continuous improvement