Senior Director, Quality department- CAPS

Senior Director, Quality Department – CAPS

You’re an important part of our future. Hopefully, we're also a part of your future! At

B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Company:
Central Admixture Pharmacy

Location:

Allentown, PA / Phoenix, AZ

Functional Area:

Quality
Working Model:
Hybrid
Days of Work:
Monday, Tuesday, Wednesday, Thursday, Friday

Shift: 5X8
Relocation Available:
No

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety.

B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the

B. Braun Group of Companies in the U.S., which includes

B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the

B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy,

B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about

B. Braun Medical, visit

CAPS®, part of the

B. Braun Group of Companies in the U.S., is 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. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities.

With experience, capacity, and a passion for safety, CAPS is your 503B solution.

• 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.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

• Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
• Directs the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods…