Quality Manager

Job Description Summary

The Quality Manager is a senior-level role responsible for overseeing and enhancing quality systems, managing complex nonconforming product issues, and ensuring comprehensive compliance with regulatory standards. This role demands a proactive approach to maintaining and improving quality system performance, mentoring teams, and serving as a leading Subject Matter Expert (SME) in quality systems applicable to storage and distribution processes. Additionally, the Quality Manager plays a critical role in ensuring regulatory compliance, quality management, and operational excellence within Distribution Centers.

Key Responsibilities:

• Lead the evaluation and disposition of held or nonconforming products with a focus on minimizing Escape incidents.
• Oversee intracompany claims and drive the resolution process.
• Conduct and manage QMS Audits, ensuring rigorous compliance and continuous improvement.
• Analyze metric data to identify trends and implement strategic quality improvements.
• Provide advanced operations support and maintain the DR License with utmost diligence.
• Act as the primary SME for ISO 13485, 21 CFR 820, and Corporate Policies/Procedures, ensuring strict adherence and application.
• Ensure the site’s compliance with local wholesale drug licenses as the designated representative.
• Mentor and train team members on QMS requirements and facilitate continuous process improvement initiatives.
• Maintain a high level of proficiency with SAP, WMS, and other ERP platforms if needed, providing expert guidance and support.
• Assume responsibility for other quality positions during times of urgency, breaks, absences, or vacation to maintain operational continuity.
• Maintain robust quality management systems, ensuring alignment with regulatory requirements and industry best practices.
• Oversee day-to-day quality processes, including inspections, process audits, and adherence to standard operating procedures.
• Collaborate with suppliers to monitor supplier performance.
• Manage validation activities for equipment, processes, and environmental monitoring systems.
• Monitor and maintain environmental conditions (e.g., temperature and pest control) to preserve product integrity.
• Prepare for and participate in internal and external audits, addressing findings promptly.
• Lead investigations into deviations, non-conformances, and customer claims.
• Ensure accurate traceability of products throughout the distribution process.
• Investigate and resolve customer claims related to service failures.
• Maintain controlled documents and manage changes effectively.
• Ensure compliance with training programs.
• Identify and mitigate risks associated with quality and compliance.
• Ensure compliance with licensing requirements and be prepared to serve as a designated representative to various boards of pharmacy.
• Collaborate with cross-functional teams, mentor staff, and drive continuous improvement.

Education & Experience:

• Bachelor’s degree preferred. Associate’s degree, or a combination of equivalent education and experience, required in lieu of a bachelor’s degree.
• Minimum of 4 years of experience in a regulated environment, with a demonstrated track record of quality system management.
• Proficiency with SAP, WMS, and other ERP platforms is required.
• Experience with Boards of Pharmacy and regulatory audits required.
• Experience as a designated representative preferred.
• Minimum 3 years of relevant experience, including at least 1 year in a supervisory role.
• Experience with quality audits.
• Experience in a warehouse environment.
• Experience in operations is a plus.
• Advanced degree (MS/MBA) is preferred.
• Professional certifications such as ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) are highly desirable.
• Experience with regulatory submissions and interactions with regulatory agencies is a plus.

Skills & Abilities:

• Demonstrated leadership ability and experience in guiding teams to achieve quality objectives.
• Strong analytical thinking and problem-solving skills with a proactive approach to addressing underperformance.
• Exceptional technical writing skills and the ability to communicate complex quality concepts clearly.
• Expertise in Microsoft Office Suite and advanced knowledge of ERP systems.
• Ability to perform physical tasks as described, with or without reasonable accommodations.
• Strong organizational skills, prioritizing assignments and providing direction.
• Effective communication (written and verbal) across all levels.
• Conflict resolution and strategic/tactical interaction with leaders.
• Talent management and customer satisfaction focus.
• Knowledge of ISO standards and financial management.

Work Environment: This position operates in both office and distribution center environments. The associate may be exposed to varying levels of noise and must be able to perform physical activities as described.

Why Join Us? 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 find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.