CAPS® (Central Admixture Pharmacy Services, Inc.)
Senior Director, Quality - CAPS
CAPS® (Central Admixture Pharmacy Services, Inc.), Phoenix, Arizona, United States, 85003
Senior Director, Quality - CAPS
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CAPS® (Central Admixture Pharmacy Services, Inc.)
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®.
CAPS®, part of the B. Braun Group of Companies in the U.S., is the nation’s largest network of outsourcing admixture pharmacies, delivering high‑quality, same‑day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the largest 503A sterile injectable outsourcing network, CAPS offers industry‑leading batch compounding on a national scale through three 503B registered outsourcing facilities.
Position Summary Senior Director, Quality – oversee all quality functions, ensuring regulatory compliance, continuous improvement, and effective communication with customers and regulators.
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.
Expertise: Knowledge & Skills
Requires breadth of professional field and industry knowledge; ability to integrate critical information and champion advanced strategies/concepts.
Directs the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees.
Judgement is required in resolving complex problems based on experience.
Represents the organization as a prime contact on projects and departmental operations, interacting with senior internal and external personnel on issues often requiring coordination across organizational lines.
Qualifications - Education / Experience / Training / Etc
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, 8 am‑5 pm. The job includes typical physical demands such as sitting, handling, and occasional lifting up to 20 lb.
Benefits
Healthcare coverage.
401(k) plan.
Tuition reimbursement.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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.
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at
CAPS® (Central Admixture Pharmacy Services, Inc.)
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®.
CAPS®, part of the B. Braun Group of Companies in the U.S., is the nation’s largest network of outsourcing admixture pharmacies, delivering high‑quality, same‑day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the largest 503A sterile injectable outsourcing network, CAPS offers industry‑leading batch compounding on a national scale through three 503B registered outsourcing facilities.
Position Summary Senior Director, Quality – oversee all quality functions, ensuring regulatory compliance, continuous improvement, and effective communication with customers and regulators.
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.
Expertise: Knowledge & Skills
Requires breadth of professional field and industry knowledge; ability to integrate critical information and champion advanced strategies/concepts.
Directs the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees.
Judgement is required in resolving complex problems based on experience.
Represents the organization as a prime contact on projects and departmental operations, interacting with senior internal and external personnel on issues often requiring coordination across organizational lines.
Qualifications - Education / Experience / Training / Etc
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, 8 am‑5 pm. The job includes typical physical demands such as sitting, handling, and occasional lifting up to 20 lb.
Benefits
Healthcare coverage.
401(k) plan.
Tuition reimbursement.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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.
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