Senior Manager, Regulatory Operations, Business Excellence

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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 P