Sr. Manager Quality Systems Compliance

BD; Sparks Corner (MD); On-site; USD 150,000 - 239,000; Full time

Job summary

BD in Sparks, MD is seeking a Sr. Manager Quality Systems Compliance to oversee regulatory compliance and quality management across global sites. The role emphasizes governance of regulatory and standards processes and driving continuous improvement using quality tools.

The successful candidate will partner with cross-functional leadership, manage Q&R risk, and report insights to executive forums, ensuring readiness and alignment with ISO and medical device regulations.

Qualifications

• 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).
• Experience managing 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.

Responsibilities

• Maintains comprehensive knowledge of applicable regulatory requirements and interpretations.
• Partners with stakeholders to lead development of strategies and tools.
• Supports Leadership Team in designing and implementing global initiatives and change management plans.
• Provides leadership and guidance in timely communication/escalation of Q&R issues to senior leadership.
• Works with business units, regions and sites to ensure Q&R Compliance Scan activities are accomplished.
• Participates in other key initiatives and projects to support the Quality Systems team.

Skills

Analytical skills

Communication

Project management

Cross-functional teamwork

PowerBI

Excel

SharePoint

ISO standards knowledge

Education

Bachelor's degree in engineering or technical field

Tools

PowerBI

Excel

Word

PowerPoint

Visio

SharePoint

Job description

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 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.

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:

(Primary Duties, Roles, and/or Authorities)

• 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.

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

Additional Locations

Work Shift

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 rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location.

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