Senior Director, Quality - CAPS

B. Braun Medical Inc. (US); Allentown (Lehigh County); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Healthcare coverage

401(k) plan

Tuition reimbursement

Job summary

A leading medical products company is seeking a Senior Director for Quality in Allentown, PA. This role involves establishing quality policies compliant with regulatory standards, managing a team, and ensuring product safety. The ideal candidate will have a Bachelor’s degree and extensive management experience, particularly in cGMP and aseptic processing. This position offers a hybrid work model with a focus on quality assurance and continuous improvement.

Qualifications

• 10-15 years of related experience and a minimum of 5 years of management experience.
• Regular and predictable attendance is required.
• Applicable industry/professional certification preferred.

Responsibilities

• Establish quality policies and procedures ensuring compliance with regulatory standards.
• Oversee investigations and responses to customer complaints.
• Manage budgets and personnel actions including hiring and performance management.

Skills

cGMP experience/training

Aseptic processing training/experience

Management experience

Frequent business travel

Education

Bachelor’s degree

Master’s degree (preferred)

Job description

Senior Director, Quality - CAPS at B. Braun Medical Inc. (US)

Company: Central Admixture Pharmacy
Job Posting Location: Allentown (6580 Snowdrift Rd), Pennsylvania, United States; Phoenix, Arizona, United States
Functional Area: Quality
Working Model: Hybrid
Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 8623

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. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. 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 for more than 28 years.

Responsibilities

• Establish organizational quality policies and procedures to ensure all applicable regulatory standards and requirements for compounded IV solutions are met.
• Ensure facilities meet qualification and validation requirements of new and existing products and processes prior to approving their release for distribution to customers.
• Drive continuous improvement efforts for products and quality systems.
• Ensure proper reporting, documentation, and record keeping as required under all regulatory agencies.
• Ensure training programs and systems effectiveness in meeting all quality training requirements.
• Oversee investigations and responses to all customer complaints and required reports to regulatory agencies.
• Identify when field action such as product holds, advisories, and recalls is needed for items already in use by customers.
• Work with Compliance to ensure timely and appropriate responses to any issues identified by regulatory agencies.
• Act as the company’s quality liaison with regulatory agencies.
• Manage departmental budgets.
• Handle personnel actions including hiring, performance management, and termination.

Qualifications

• Bachelor’s degree required; Master’s degree preferred.
• 10‑15 years of related experience, plus a minimum of 5 years of management experience.
• Applicable industry/professional certification preferred.
• cGMP experience/training required; aseptic processing training/experience required.
• Regular and predictable attendance.
• Frequent business travel required.

Schedule

Monday‑Friday, 8:00 am – 5:00 pm. Hybrid working model.

Physical Demands

• Light work: Exert up to 20 lb occasionally; up to 10 lb frequently.
• Lift, carry, push, pull, and reach as required.
• May stand, walk, and climb stairs or ladders occasionally.

Environment & Work Conditions

Office environment with moderate noise intensity. Reasonable accommodations available.

Benefits

Healthcare coverage, 401(k) plan, tuition reimbursement, and other benefits as part of the B. Braun benefits package.

Equal Employment Opportunity

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. All qualified applicants will receive consideration for employment without regard to any protected status.