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 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%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.