Sr. Manager Quality Systems Compliance

BD; Sparks Corner (MD); Sur place; USD 150 000 - 239 000; Plein temps

Avantages offerts par ce poste

Total Rewards program

Competitive compensation & benefits

Résumé du poste

BD in Sparks, MD is seeking a Sr. Manager Quality Systems Compliance to lead regulatory and quality programs across the global organization. You will drive readiness, governance, and reporting of Q&R risks to executive forums.

This role requires partnering with cross-functional teams and delivering improvements in a highly regulated environment. As GPO, you will oversee strategies and tools for effective execution, foster change management, and use SharePoint, PowerBI, and Excel to visualize

Qualifications

• B.S./B.A. in engineering or technical field.
• 8+ years in a regulated field (medical devices, IVDs, pharmaceuticals, or biologics).
• Experience with Quality/Regulatory/Compliance teams and/or improvement operations.
• Process excellence certification (SSGB, lean, etc.) preferred.

Responsabilités

• Maintains knowledge of regulatory requirements and trends and communicates insights for improvement.
• Leads development of strategies and tools for effective execution and monitoring as GPO.
• Supports global initiatives and change management planning.
• Communicates/escalates issues to senior leadership via escalation process.
• Coordinates data collection, analysis, reporting, and global site list maintenance for Q&R scans.
• Participates in cross-functional initiatives to support Quality Systems.

Connaissances

Regulatory compliance

Quality systems

Project management

Cross-functional collaboration

PowerBI

Excel

Formation

B.S. or B.A. in engineering or technical field

Outils

SharePoint

Excel

PowerBI

Visio

PowerPoint

Description du poste

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We Are The People Who Give Possibilities Purpose

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.

Job Description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT),byapplyingtothis role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientificexpertiseacross biology, chemistry, and physics. Waterscollaboratewith analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance.Through a shared culture of relentless innovation, Waters’ passionate team of approximately16,000colleaguespartner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

Job Summary

The Sr. Manager Quality Systems Compliance is responsible for establishing an ongoing state of readiness by ensuring visibility of compliance risks, governance of the regulatory and standards management process for the organization and promoting continuous improvement through the effective use of quality tools and processes. This role scans the internal Waters businesses for areas of Quality & Regulatory compliance risk. The role also maintains Quality & Regulatory (Q&R) Compliance metrics and provides reporting and visibility to various governance forums including the reporting of Q&R Compliance risks to executive levels. As Global Process Owner (GPO), Regulation & Standards Compliance Management, this role is accountable and responsible for ensuring effective implementation of the company’s regulatory and standards management processes. This role partners with cross-functional, business unit and regional leadership on the assessment, and implementation planning if required, for new and revised regulations and standards.

Job Responsibilities

• Maintains comprehensive knowledge of applicable regulatory requirements and interpretations, proactively monitors emerging Q&R compliance trends, and effectively communicates relevant external insights across Waters to support ongoing compliance and drive continuous improvement.
• As GPO Partners with stakeholders to lead the development of strategies and tools to ensure effective execution and monitoring.
• Supports Leadership Team in designing and implementing global initiatives and change management plans
• Provides leadership and guidance in timely communication/escalation to senior leadership of issues associated with Q&R Compliance risk via the Waters escalation process.
• Works with business units, regions and sites to ensure Q&R Compliance Scan activities are accomplished; includes content / visualization development, data collection, communication, analysis, reporting and maintenance of the global site list. Reviews the data collection methodology to drive efficiency and effectiveness.
• Participates in other key initiatives and projects as necessary to support the Quality Systems team.

Education And Experience

• B.S. or B.A. degree, preferably in engineering or a technical field.
• 8+ years in a regulated field (medical devices, IVDs, pharmaceuticals, or biologics) with
• experience related to the management and administration of Quality/Regulatory/Compliance and/or Improvement operations.
• Process excellence experience/certification preferred (SSGB, lean, etc.)
• Strong influencing, communication and project management skills in a global matrix environment.

Knowledge And Skills

• Proficient analytical, problem-solving, listening, and interpersonal skills, results oriented.
• Ability to successfully interface with all levels of the organization and create a collaborative environment.
• Excellent oral and written skills with the ability to communicate information to various levels of the Organization.
• Proven experience in working in a cross-functional team environment as well as the ability to function independently.
• Skilled in working with electronic systems (e.g. SharePoint, PowerBI, Excel, Word, PowerPoint, Visio) and the capacity to learn new tools and technologies as needed.
• Knowledge of Quality System Regulations, applicable ISO standards and other related US and international regulations and standards that apply to the medical device/diagnostics industry.
• Working knowledge on quality matters involving the design, development, manufacture and distribution of medical devices and IVDs.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit

https://bd.com/careers.

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.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$149,600.00 - $239,400.00 USD Annual