B. Braun Melsungen AG
Senior Director, Quality department- CAPS
B. Braun Melsungen AG, Phoenix, Arizona, United States, 85003
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 www.bbraunusa.com
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.
Position Summary Responsibilities: Essential Duties
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.
Expertise: Knowledge & Skills
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 and employees. Determines actual organizational structure and allocation of resources.
Judgement is required in resolving complex problems based on experience.
Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.
Expertise: Qualifications – Education / Experience / Training / Etc Required
Bachelor’s degree required, Master’s degree preferred.
10‑15 years related experience, plus a minimum of 5 years management experience required.
Applicable industry/professional certification preferred.
Regular and predictable attendance.
Frequent business travel required, cGMP experience/training required, Aseptic processing training/experience required.
Schedule is M‑F, 8am‑5pm.
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.
Physical Demands Light work – exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Noise Intensity: Moderate
Occasionally: Other
Frequently: N/A
Constantly: Office environment
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal.
#J-18808-Ljbffr
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 www.bbraunusa.com
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.
Position Summary Responsibilities: Essential Duties
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.
Expertise: Knowledge & Skills
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 and employees. Determines actual organizational structure and allocation of resources.
Judgement is required in resolving complex problems based on experience.
Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.
Expertise: Qualifications – Education / Experience / Training / Etc Required
Bachelor’s degree required, Master’s degree preferred.
10‑15 years related experience, plus a minimum of 5 years management experience required.
Applicable industry/professional certification preferred.
Regular and predictable attendance.
Frequent business travel required, cGMP experience/training required, Aseptic processing training/experience required.
Schedule is M‑F, 8am‑5pm.
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.
Physical Demands Light work – exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Noise Intensity: Moderate
Occasionally: Other
Frequently: N/A
Constantly: Office environment
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal.
#J-18808-Ljbffr