Simtra BioPharma Solutions partners with pharmaceutical and biotech companies to bring sterile injectable products to market with a strong emphasis on quality and continuous improvement
Job Summary
Simtra BioPharma Solutions partners with pharmaceutical and biotech companies to bring sterile injectable products to market with a strong emphasis on quality and continuous improvement.
The Associate Director of Quality Assurance provides leadership and direction for Filling and Finishing Quality Line Operations, ensuring compliance with procedures and regulatory standards while fostering teamwork and productivity.
Employees are eligible for comprehensive benefits including medical and dental coverage, 401(k) with company match, paid time off, adoption reimbursement, education assistance, and onsite campus amenities.
Matching Summary
Simtra BioPharma Solutions partners with pharmaceutical and biotech companies to bring sterile injectable products to market with a strong emphasis on quality and continuous improvement.
Skills & Requirements
Must-have
Quality Assurance leadership
Compliance with cGMP and FDA Annex One
Team management and development
Quality data tracking and reporting
Continuous improvement project leadership
Regulatory audit representation
Nice-to-have
Strong communication and teamwork
Experience with international regulatory bodies
Budget development and management
Customer issue resolution
Use of enterprise software tools
Support for aseptic filling operations
Key Requirements
Bachelor's degree in Life Science field
12 years pharmaceutical manufacturing experience
Minimum 10 years management experience
In-depth knowledge of FDA Annex One
Ability to qualify for Class A/B aseptic facilities
Proficiency in Microsoft Office and enterprise software