QA Quality Systems & Compliance Senior Manager

Overview

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.

• 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.

• 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.

• Reports to:
  
  Director/VP of Quality Assurance or equivalent senior leadership.
• Supervises:
  Quality Systems and Compliance team members.

BD prioritizes on-site collaboration to foster creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, a minimum of 4 days of in-office presence per week is encouraged to maintain our culture of excellence and ensure smooth operations. Remote or field-based positions will have different workplace arrangements as indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To learn more about BD visit https://

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift