QA Quality Systems & Compliance Senior Manager

Becton Dickinson Medical Devices•El Paso, TX

23h•Onsite

About The Position

The QA Quality Systems & Compliance Senior Manager is responsible for leading and overseeing the development, implementation, and maintenance of quality management systems and compliance programs within BD’s pharmaceutical and medical device operations. This role ensures adherence to global regulatory requirements, industry standards, and internal policies to support product quality, patient safety, and operational excellence. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
Minimum 8-10 years of progressive experience in quality assurance within pharmaceutical (preferred) and/or medical device manufacturing.
Experience managing teams, strong leadership, communication, and interpersonal skills with the ability to influence at all levels.
Proven track record managing quality systems, deep knowledge of regulatory requirements (FDA, EMA, ISO 13485, GMP, GxP), and industry best practices.
Experience managing audits and regulatory inspections.
Proficiency with quality management software and Microsoft Office Suite.
Excellent analytical, problem-solving, and decision-making abilities.
Ability to work effectively in a global, cross-functional team environment.

Responsibilities

Lead the design, deployment, and continuous improvement of BD’s Quality Management Systems (QMS), including document control, CAPA, change control, deviation management, audit management, post market compliance and training systems.
Ensure compliance with global regulatory requirements such as FDA, EMA, ISO 13485, GMP, and GxP standards.
Develop, review, and maintain quality policies, procedures, and work instructions aligned with BD’s corporate standards and regulatory expectations.
Manage internal and external audits, including regulatory inspections, internal audits, and customer audits, ensuring timely and effective resolution of findings.
Collaborate cross-functionally with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, and other stakeholders to embed quality and compliance into operational processes.
Oversee quality management programs to ensure compliance with BD’s quality standards.
Lead root cause investigations, situation analysis and risk assessments related to quality system deviations and non-conformances.
Provide leadership, coaching, and development to the Quality Systems and Compliance team, promoting a culture of accountability and continuous improvement.
Monitor and report on key quality metrics and compliance KPIs to senior leadership, identifying trends and areas for improvement.
Support regulatory submissions and inspections related to quality systems and compliance.
Drive training and awareness programs to ensure all employees understand their roles in maintaining quality and compliance.
Oversee the function and lead the compliance of C2C technical training, assuring the training of new associates and retraining as required.
Lead quality system projects and initiatives that support BD’s business objectives and regulatory changes.