BD · 1 month ago
Associate Director, Quality Management
Columbus, NE
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expBD is one of the largest global medical technology companies in the world, and they are seeking an experienced Associate Director of Quality Management. This leadership role will drive organizational change and ensure compliance with quality systems, regulatory requirements, and customer specifications while fostering a culture of continuous improvement.
Health CareMedical DeviceTechnical Support
Responsibilities
Develop and maintain comprehensive plant quality and compliance strategies, policies, and frameworks that drive organizational excellence and regulatory adherence
Lead, coach, and develop a high-performing quality team, fostering professional growth while building a cohesive department that maintains strong quality presence across manufacturing areas
Serve as the plant "management representative" for notified bodies, regulatory authorities, and customers, managing audits and ensuring effective resolution of findings
Build influential networks with worldwide Quality and Regulatory functions, other plant Quality Leaders, and key global functions (R&D, Engineering, Supply Chain) to ensure alignment around priorities
Direct operational leadership in planning and managing comprehensive quality systems including: Validation programs, Internal and customer quality audits, Compliance audits, Corrective and preventive action programs (CAPA), GMP training initiatives, Quality engineering, Change control processes, Document control systems, Complaint management
Identify quality improvement opportunities within operations and partner with peers in Manufacturing, Engineering, and Supply Chain to develop and implement innovative solutions
Ensure the quality organization is properly staffed, organized, and resourced to fulfill cGMP obligations and BD procedures
Champion and promote a culture of quality excellence throughout the plant, driving organizational change that elevates quality standards
Qualification
Required
Bachelor's degree in a technical or science-related field
10+ years of experience in pharmaceutical/biopharmaceutical manufacturing environments (highly preferred)
10+ years in plant Quality leadership roles with demonstrated success (highly preferred)
Comprehensive knowledge of 21CFR parts 820 (QSR), 210/211, ISO9001, 13485 with experience leading or participating in related audits and inspections
Ability to read and write and converse in English
Willing and able to uphold BD Values
Regular, punctual attendance is an essential job function
Preferred
Advanced degree in a technical or science-related discipline
Experience in production or engineering management
Multi-country/multi-cultural experience
Proficiency with quality management systems and tools including SAP, Trackwise, MS Office, Minitab, and SAS
Benefits
Competitive pay
Access a portion of your pay before pay day with DailyPay
Healthcare coverage: No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.
Preventive care covered at 100%.
Dental and vision insurance at group rates.
Paid parental leave up to 6 weeks
Adoption assistance plan
401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation
Company paid basic life and AD&D insurance
Tuition reimbursement
Discounted home, auto and pet insurance
Paid holidays and vacation (pro-rated the first year based on actual start date)
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD 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
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
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