Director of Quality Control
3 weeks ago
Our client is seeking a dedicated and experienced Director of Quality Control to lead all aspects of their Quality Control functions. This role offers the opportunity to continuously review and improve quality philosophy, practices, and procedures, ensuring that all products and related information and services are compliant with company and regulatory requirements.
What You’ll Do
Manage stability programs including transportation testing, temperature variation, storage testing, and stability.
Instigate and coordinate initiatives to improve overall quality and customer satisfaction.
Provide expert technical analysis and evaluation of quality control issues impacting CMC projects.
Oversee QC method transfers and method validations.
Maintain stability trending databases and oversight on active programs.
Oversee Reference Standard program including establishing and maintaining reference standards.
Interact with suppliers during CMO selection and throughout projects for problem solving.
What You Bring
BS/MS/ PhD in life science or chemistry.
Minimum of 15 years of experience in an FDA-regulated pharmaceutical environment performing QC functions.
Minimum of 10 years management experience in a GMP Quality Control laboratory.
Current knowledge of analytical and validation principles, local and international regulations, and regulatory policies.
Skilled in directing and managing people, communicating with Regulatory agencies, customers, employees at all levels of the organization.
Demonstrated ability to make risk-based assessments requiring a high degree of understanding of the overall site objectives.
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