B. Braun Medical Inc. (US) · 2 hours ago
Senior Director, Quality - CAPS
Allentown, PA
Full-time
Hybrid
Director/Executive
10+ years expB. Braun Medical Inc. is a leader in infusion therapy and pain management, committed to enhancing patient safety. The Senior Director, Quality role involves establishing quality policies and overseeing compliance with regulatory standards for compounded IV solutions.
Clinical TrialsEducationHealth CareManufacturingMedical DevicePharmaceutical
Responsibilities
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
Qualification
Required
Bachelor's degree required
10-15 years related experience, plus a minimum of 5 years management experience required
Regular and predictable attendance
Frequent business travel required
cGMP experience/training required
Aseptic processing training/experience required
Preferred
Master's degree preferred
Applicable industry/professional certification preferred
Benefits
Healthcare
A 401(k) plan
Tuition reimbursement
Company
B. Braun Medical Inc. (US)
B.
10001+ employees
H1B Sponsorship
B. Braun Medical Inc. (US) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (10)
2023 (14)
2022 (6)
2021 (12)
2020 (9)
Funding
Current Stage
Late StageTotal Funding
$0.03MKey Investors
Ben Franklin Technology Partners of Northeastern Pennsylvania
2020-10-27Debt Financing· $0.03M
Leadership Team
Leigh Ann Stradford
Senior Vice President and Chief Human Resources Officer
Rob Albert
Senior VP Marketing
Recent News
2025-12-06
Company data provided by crunchbase