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Senior Manager

3 months ago

Salem, Oregon, United States Church & Dwight Full time
A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. Role Summary Reporting to the Vice President of Global Regulatory Affairs, the Senior Manager of Global Regulatory Systems and Compliance is responsible for the development and implementation of global regulatory systems and regulatory surveillance programs, tools and processes to enable the effective and efficient delivery of the Company's regulatory obligations. The position will be responsible for ensuring regulatory IT systems and procedures support global regulatory activities, including registration, surveillance and information management. This position is also responsible to drive standard work, process harmonization and operational efficiency across the GRA organization to ensure compliance to global requirements and Company policy. A key objective of this role is to elevate the Company's regulatory compliance position by building regulatory intelligence and digital infrastructure. This individual must proactively address complex regulatory issues and partner with global GRA colleagues to monitor the outside regulatory environment. By identifying and communicating current capabilities and internal and external trends, s/he will design tools, processes and training to address capability gaps in the department, with an eye to the future. In addition, the role must engage with and influence partners in Marketing, R&D, QA and SC, helping Global Regulatory achieve key business goals and expectations. The Senior Manager of Global Regulatory Systems and Compliance will drive execution efforts across cross-functional teams comprised of Regulatory and other functional SMEs, IT resources, and third-party partners. This position may supervise full-time employees, interns, contractors, consultants or temporary workers. Role Accountabilities and Responsibilities
  • Ensure Regulatory procedures are reviewed, revised appropriately and comply with C&D policies and regulatory requirements (including regulator and Notified Body guidance)
  • Identify processes needed to implement Regulatory activities
  • Lead the development and implementation of global regulatory procedures that comply with C&D policy and regulatory requirements
  • Approve global regulatory system documentation (for example, GSOPs)
  • Establish and maintain sufficiently detailed procedures to ensure that, where applicable, controlled records are maintained throughout the record's lifecycle. Controlled records include those records needed to provide evidence of conformity to regulatory requirements (e.g., Declarations of Conformity, product licenses, facility registrations)
  • Evaluate the application, impact, sequence, and interaction of Regulatory processes throughout the Global Regulatory Affairs organization to promote consistency, simplicity and proportionality in core work processes
  • Lead global projects and initiatives related to GRA applications and business processes.
  • Develop and maintain the Global Regulatory IT digital roadmap.
  • Act as Regulatory Affairs lead to the Global Intelligence Committee and provide oversight of GRA implementation of the Global Intelligence Strategy and Surveillance Process.
  • Develop and maintain processes to track and monitor regulatory system health. Report on key performance indicators or other metrics for GRA.
  • Support development and delivery of Global Regulatory Affairs training. Support people managers in the department to ensure training matrices are maintained.
Strategy and Functional Expertise
  • Knowledge of policies, procedures and metrics
  • Demonstrated aptitude and experience with designing and implementing IT systems or solutions
  • Keeps accurate documentation and submits detailed reports to appropriate executives
  • Aptitude in data analysis to report and present effectiveness of business processes
  • High attention to detail, organization and accuracy
  • Contributes to policy, strategy implementation, and execution of relevant policies and procedures across manufacturing sites
Leadership and Influence
  • Well organized; demonstrates forward leaning and high initiative
  • Leads and directs strategic programs focused on meeting regulatory company requirements related to training, intelligence and information management
  • Demonstrates broad business orientation
  • Shows personal commitment to the vision and creates energy and optimism
  • Promotes a culture of collaboration and teamwork across organizational boundaries
  • Keeps current on regulatory trends in the external environment
Program Development/Program Management
  • Tests, confirms and/or improves regulatory systems and processes to ensure they are in control and being followed
  • Solves issues quickly and efficiently
  • Ensures stakeholder satisfaction
  • Delivers project tasks on time
  • Oversees implementation to ensure adherence to new requirements
  • Sets requirements for suppliers and monitors their compliance
  • Ability to prioritize and handle multiple projects simultaneously
  • Communicates and engages appropriately with vendors/suppliers
  • Conducts sensitive conversations in a confidential manner with vendors/suppliers
  • Provides clear direction, removes obstacles, and holds self and others accountable
Impact/Reach
  • Strong execution skills
  • Demonstrates agility and connectivity across the organization
  • Actively builds connections and partnerships with others, internally and externally
  • Ability to work with all levels of PD, supply chain and technology teams to build relationships across functions
  • Strong communications and the ability to adjust content and delivery to meet the needs of the audience
Education and Experience
  • University degree from an accredited institution in a related field
  • Professional typically with over 7 years' technical experience and a demonstrated track record
  • Contributions balanced between strategy and functional execution elements; independent
  • Supervisory experience is strongly preferred
Skills and Competencies
  • Demonstrated aptitude and experience with designing and implementing IT systems or solutions
  • Practical understanding, interpretation, and application of ISO13485 or other Quality Management Systems is desired
  • Excellent verbal and written skills
  • Ability to prioritize and to handle multiple projects simultaneously.
  • Ability to work with all levels of management and to build relationships across disciplines
#piq
#LI-Remote Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities. For more information on our company, our brands and our culture visit us at Category:Marketing & Biz Dev, Keywords:Compliance Manager, Location:REMOTE, OR-97458