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Manager of Compliance in Life Sciences Services
2 months ago
Job Overview
Position Summary
We are a leading force in the medical technology sector.
BD stands as one of the foremost global medical technology enterprises, dedicated to enhancing health worldwide. Our mission is ambitious, requiring the creativity and dedication of our diverse teams—from design and engineering to the production and marketing of our extensive range of MedTech products. We strive to turn challenges into opportunities through innovative solutions.
We recognize that our people are the cornerstone of our evolution. Join us in an environment that fosters personal and professional growth, enabling you to reach your full potential. Become a part of our journey to make the impossible possible.
Role Summary:
The Life Sciences US Service Quality and Compliance Manager is responsible for overseeing a team and ensuring that the US Service Organization adheres to established procedures, BD Quality Systems, FDA regulations, and other applicable standards. The US Service Delivery Organization encompasses Field Service/Applications, Repair Depot, and support teams.
Key Responsibilities:
- Establish and disseminate key performance indicators to assess compliance with BD Quality systems and regulatory requirements. Lead Quality Management Reviews with senior leadership.
- Oversee US LS Service assigned Corrective and Preventive Actions (CAPAs), ensuring they are completed in a timely manner.
- Enhance quality metrics, policies, and procedures for the US Service organization.
- Actively participate in the Complaint Handling Process, ensuring service teams comply with company protocols and meet quality standards and KPIs related to Work Order management.
- Collaborate with stakeholders to perform Impact assessments for Service Tools Calibration, ensuring tools are consistently within acceptable limits.
- Deliver Quality training for both new and existing Service associates, including Good Distribution Practices (GDP), to ensure compliance.
- Create tools and training resources for all transactional US Service Teams regarding adherence to the company’s Quality System and compliance with privacy and security laws, including HIPAA regulations.
- Maintain comprehensive training records for US Service associates, facilitating easy access for audit purposes. Work with management to ensure associates meet training compliance.
- Serve as the primary representative for US Service during internal and external Quality Audits, ensuring readiness from a Complaint and Compliance perspective.
- Collaborate closely with Field Service, Complaint teams, and technical support to ensure compliance and develop strategies for enhancing overall compliance.
- Play a crucial role in maintaining data integrity within US Service systems and managing user access for critical applications.
- Ensure adherence to OSHA regulations and timely reporting of Environmental Health & Safety (EH&S) concerns and incidents.
Qualifications:
- Minimum of 5 years of experience in Technical Services or Customer Support within the Life Sciences or Medical Diagnostics/Healthcare sectors, with prior management experience preferred.
- Bachelor's degree required; fields such as Medical Technology, Biological Services, or Engineering are preferred.
- In-depth knowledge of Quality Systems and Regulations within the specified industries, including Customer Complaint and CAPA management.
- Proven track record of success in complex, matrixed organizations, demonstrating leadership and organizational skills in cross-functional team environments.
- Strong interpersonal skills, including effective communication and conflict resolution abilities.
- Exceptional written, verbal, and presentation skills, with a high degree of organization and the ability to manage multiple tasks effectively.
- A mindset focused on continuous improvement.
- Ability to engage effectively with customers at all levels, as well as internal and external business partners, vendors, and media.
- Experience with ISO 9000/ISO 13485 is preferred.
- Willingness to travel up to 15%.
Why Work with Us?
A career at BD means being part of a team that values your contributions and encourages you to express your authentic self. We foster an environment where collaboration, accountability, and continuous learning are paramount. To realize our mission, we seek individuals who can appreciate the broader perspective and understand the human narrative that drives our work. At BD, you will find a culture that promotes growth and fulfillment, allowing you to make a meaningful impact in improving global health.