Sr. Manager Quality Systems Compliance
BD
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 description
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.
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)
- 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)
- Knowledge of Quality System Regulations, applicable ISO standards and other related US and international regulations and standards
- Working knowledge on quality matters involving the design, development, manufacture and distribution of medical devices and IVDs
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Unlimited PTO
Company overview
BD (Becton, Dickinson and Company) is one of the world's largest global medical technology companies, founded in 1897 and headquartered in Franklin Lakes, New Jersey. As a Fortune 500 company, BD specializes in developing, manufacturing, and selling medical devices, instrument systems, and reagents across three primary segments: BD Medical, BD Life Sciences, and BD Interventional. The company's extensive product portfolio includes medical equipment such as syringes, needles, infusion systems, diagnostic instruments, flow cytometers, and surgical devices. With over 70,000 employees worldwide and operations in virtually every country, BD focuses on advancing healthcare through innovations in medical discovery, diagnostics, and care delivery. The company has a rich history of pioneering medical technologies, including the first insulin injection device, the Vacutainer blood collection system, and numerous safety-engineered medical devices. BD's mission centers on improving clinical therapy for patients and enhancing clinical processes for healthcare providers while addressing global health challenges through strategic partnerships and continuous innovation.