Senior Manager, Organizational Operations and Compliance Business Continuity
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Manager, Organizational Operations and Compliance Business Continuity in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager, Organizational Operations and Compliance Business Continuity working on the Regulatory Operations and Cross Functional team, you will be empowered to lead, support and execute on all vendor management activities, building/maintaining external relationships and ensuring alignment with business and regulatory strategies. A typical will include:
Lead, support and execute on all vendor management activities, building/maintaining external relationships and ensuring alignment with business and regulatory strategies. Provide operational support in collaboration with internal, external and cross-functional stakeholders as needed. Lead and collaborate in the development and implementation of new or modified policies, processes and procedures. Lead, collaborate and support in the execution and management of key strategic initiatives, as needed.
- Collaborate and lead the development and implementation of partnership operating models; and provide vendor oversight as applicable.
- Collaborate with internal and external stakeholders to provide operational support and execution of GRA initiatives, such as budget planning, capacity planning, headcount and other reporting, as needed.
- Provide leadership/oversight in mentoring junior staff and/or internal/partners in relevant content.
- Facilitate and operationally support global business continuity initiatives including capacity planning, audits, inspections and budget cycle, time-tracking, providing data analyses and consolidation.
- Collaborate in ongoing process improvement initiatives with functional owners and vendor/partner(s) to deliver increasing operational efficiency in all business partner processes.
- Develop and maintain monthly performance and management reports/dashboards and oversee accuracy and timeliness of all business partner reporting.
- Lead workstream activities designed to facilitate integration, transition and transformation.
- Collaborate and assist in the execution of strategic and change management initiatives and provide project management expertise on initiatives, as needed.
- Collaborate to improve communications; and facilitate/assist in vendor/partner internal/external stakeholder meetings and briefings.
- Track and monitor GRA and vendor/partner risks and issues, support mitigation plans and issue escalation and resolution
EDUCATION, EXPERIENCE AND SKILLS:
- Bachelor s Degree in a science or business-related field.
- 5 + years experience in Pharmaceutical industry, with 5 years in Regulatory Affairs, research and development or quality assurance/compliance or related experience preferred.
- Familiarity with inspections and audit procedures and ability to identify proactively and anticipate risk of non-compliance in a complex environment.
- Demonstrated knowledge of global health authorities, regulations, product approval and lifecycle processes for major markets and of pharmaceutical and regulatory affairs requirements and practices.
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment. Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
- Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing.
- Excellent analytical, technical and problem-solving skills
- Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.