Sr. Manager Quality Systems Compliance

Becton Dickinson Medical Devices • Sparks, NV

4d • Onsite

About The Position

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.

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.

Requirements

• 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.
• Strong influencing, communication and project management skills in a global matrix environment.
• 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.

Nice To Haves

• Process excellence experience/certification preferred (SSGB, lean, etc.)

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.

Benefits

• Total Rewards program
• Competitive package of compensation and benefits programs
• Salary or hourly rate ranges reward associates fairly and competitively
• Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location

What This Job Offers

• Job Type: Full-time
• Career Level: Manager