"Alerted.org

General Description:

The Senior Manager of Business Excellence plays a pivotal role for driving the successful execution of Global Regulatory Operations Strategy & Innovation programs and projects in a dynamic and highly regulated industry and will interact at all levels of the organization.

This position will require strong leadership skills with a blend of expertise in process optimization and project management. The ideal candidate will have experience working in a diverse team of cross-functional project teams, fostering collaboration, innovation, and operational excellence.

Essential Functions of the job:

+ Lead process improvement/optimization projects from inception to implementation to improve processes and the efficiency within the organization.

+ Monitor and support use, adoption, and improvement of GROSI programs, systems, policies, procedures, and controls.

+ Work with a diverse team comprised of cross functional stakeholders and team members to ensure processes and procedures remain in a compliant state.

+ Provide project management support on execution of the implementation plan working closely with cross-functional stakeholders.

+ Support process, mapping activities, maintain trackers and publish metrics reports.

+ Provide timely and accurate updates on projects and activities as required by leadership as well as present strategic vision and status updates to senior management.

+ Investigate current workflows and process-related pain-points and propose solutions from current to ideal end-state; develop and present proposals to key stakeholders and leaders for buy-in on proposed end-state.

+ Measure the efficiency and utilization of newly implemented workflows and iterate on the process for continued refinement.

+ Develop strong collaborative relationships with key stakeholders across BeOne to identify opportunities for future process improvement initiatives.

+ Ability to foresee implications of various courses of action when making decisions and mitigate against any potential problems.

Supervisory Responsibilities:

+ No

Education/Experience:

+ Bachelor's Degree with 7+ years of IT, consulting, and/or project management experience required.

+ 7+ years in the pharmaceutical/bio-pharmaceutical industry with prior Regulatory Operations related experience preferred.

Computer Skills:

High Level of Competency Required:

+ Veeva Vault Experience Preferred

+ Microsoft Office and Adobe systems

+ Project Management Tools: Microsoft Project or Smartsheet

+ Regulatory Information Management (RIM) Systems (Veeva Vault, Liquent InSight, etc.)

+ Collaboration Tools (SharePoint, etc.)

+ Data Visualization Tools (PowerBI, etc.)

Other Qualifications:

+ Resilient profile with the ability to deliver in an ambiguous environment.

+ Ability to think strategically with a focus on process improvement and optimization.

+ Excellent verbal and written skills, attention to detail, time management and prioritization skills, and problem-solving capabilities are a must have.

+ Candidates will demonstrate an ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.

+ The ideal candidate will be accountable for their work, show a great deal of initiative and leadership, displaying integrity in everything they do, thriving in a team environment, and seeing excellence as the only measure of success.

+ Experience in managing shifts in competing priorities or unforeseen challenges, without compromising quality, attention to detail and timeline deliverables.

+ Experience in working both independently and in a group environment.

+ Familiarity with pharmaceutical development and Regulatory global submissions is a plus.

+ Excellent presentation and facilitation skills

+ Working knowledge of regulations, processes and industry standards that govern regulated systems, records retention, and computer validation quality assurance for the management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.

+ Demonstrated ability to facilitate, lead, and manage the establishment of procedures.

+ Able to work in a fast-paced environment and effectively manage workload and deliverables under pressure.

**Travel:** <15%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.