CAPS® (Central Admixture Pharmacy Services, Inc.) · 9 hours ago
Senior Director, Quality - CAPS
Allentown, PA
Full-time
Onsite
Director/Executive
10+ years expB. Braun Medical Inc. is a leader in infusion therapy and pain management, committed to enhancing patient safety. The Senior Director of Quality at CAPS will establish quality policies, oversee compliance with regulatory standards, and drive continuous improvement in quality systems.
Pharmaceuticals
Responsibilities
Establishes organizational quality policies and procedures to ensure all applicable regulatory standards and requirements for compounded IV solutions are met
Ensures facilities meet qualification and validation requirements of all new and existing products and processes prior to approving their release for distribution to customers
Drives continuous improvement efforts for products and quality systems
Ensures proper reporting, documentation and record keeping as required under all regulatory agencies
Ensures training programs and systems effectiveness in meeting all quality training requirements
Oversees investigations and responses to all customer complaints and all required reports to regulatory agencies
Identifies when field action such as product holds, product advisories and product recall are needed for items already in use by customers
Works with Compliance to ensure timely and appropriate responses to any issues which may be identified by Regulatory agencies
Oversees the internal Quality function, acting as the Company’s Quality liaison with regulatory agencies
Responsible for department budgets
Responsible for personnel actions including hiring, performance management, termination
Qualification
Required
Bachelor's degree required
10-15 years related experience required
Minimum of 5 years management experience required
Regular and predictable attendance required
Frequent business travel required
cGMP experience/training required
Aseptic processing training/experience required
Preferred
Master's degree preferred
Applicable industry/professional certification preferred
Benefits
Healthcare
A 401(k) plan
Tuition reimbursement
Company
CAPS® (Central Admixture Pharmacy Services, Inc.)
CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase