Director, Quality 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

Job Posting

Location:

Phoenix, Arizona, United States

Functional Area:

Quality

Working Model:
Onsite

Days of Work:
Friday, Thursday, Wednesday, Tuesday, Monday

Shift: 5X8

Relocation Available:
No

Requisition

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, 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.

CAPS is part of the

B. Braun Group of Companies in the U.S.

Plan, organize and direct the activities related to the CAPS Quality function to ensure timely completion of the group tasks. The CAPS Director, Quality is also responsible for the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to suppose the company goals while complying with regulatory requirements.

• Oversees the performance of functional group to assure that products and processes meet company and regulatory requirements.
• Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
• Provide technical assistance and direction to the other functional groups. Interface with regulatory agencies during routine audits, field complaint investigations, and technical interchanges to present the company's view point.
• Develop, direct and implement validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
• Supervises the implementation of internal audit program to determine any deficiencies in the Admixing / Compounding Pharmacy Operations as they relate to current regulations.
• Directs the investigation of excursions in Admixing / Compounding Pharmacy or other related operations resulting in abnormal operation rejections. Resolves nature of the cause, impact, disposition and corrective actions.
• Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
• Provides supervision to CAPS Quality Control Coordinators.

• Broad knowledge of scientific theories, instrumentation and techniques
• Thorough knowledge of GMPs, GLPs and pharmaceutical products.
• Familiar with the USP, FDA, Aseptic Process, and other regulatory guidelines
• Working knowledge of all phases of company and laboratory operations

Required:

• B.A./B.S. degree in related science
• 10 or more years of experience in an admixing, pharmaceutical, or medical device company.
• Minimum of 5 years previous managerial experience
• Frequent travel required
• cGMP training/experience required.
• Aseptic processing training/experience desired. Training will be provided.

Desired:

• Advanced degree

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

• Business travel, Driver's…