Director, Organizational Operations and Compliance - Business Continuity, Global Regulatory Affairs
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 an Director, 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 Director, Organizational Operations and Compliance - Business Continuity on the Research and Development team, you will be empowered to lead and define all vendor management activities, effectively building and maintaining external vendor/partner relationships, ensuring alignment with business and regulatory strategies. A typical will include:
- Lead and define all vendor management activities, effectively building and maintaining external vendor/partner relationships, ensuring alignment with business and regulatory strategies.
- Lead the development, implementation, and maintenance of organizational processes and procedures, operational excellence, and strategic initiatives in collaboration with internal, external and cross-functional stakeholders
- Lead and define internal/external performance and quality SLA's, KPIs, and metrics.
- Lead and define the development and implementation of GRA communication strategies and information distribution.
- Responsible for vendor management and oversight. Lead and collaborate on the development and implementation of partnership operating models. Lead vendor/partner(s) operating committee meetings and initiatives.
- Lead and define process improvement strategies and initiatives with vendor/partner(s), GRA and Takeda cross-functional resources.
- Accountable for ensuring sourcing strategies and vendor/partner expectations align with business and regulatory strategies to ensure best performance and outcomes for Takeda and GRA.
- Lead and manage vendor/partner compliance to all agreement terms and conditions, company policies, standards. Proactively identify areas of potential risk and develop proactive risk mitigation plans and manage issue resolution, incorporating learning to strengthen partnership processes.
- Oversee performance data, review results against goals. Define management reports/ dashboards and provide quarterly feedback to business partners and leadership team.
- Oversee day-to-day GRA organizational operations and business continuity initiatives (capacity planning, audits, inspections and budget cycle, time-tracking, data reporting).
- Lead and define the development and execution of strategic and change management initiatives.
- Oversee and mentor direct reports, providing leadership and training to support professional development.
- Responsible for demonstration of Takeda Leadership behaviors.
EDUCATION, EXPERIENCE AND SKILLS:
- Bachelor's Degree in a science or business-related field.
- 10 + years' experience in Pharmaceutical industry, with 10 years in Regulatory Affairs, research and development or quality assurance/compliance.
- Have 5+ years' experience managing a vendor management office for a pharmaceutical/medical company; including contract negotiation, vendor performance management, preparing and evaluating RFPs, relationship management, and a strong understanding of project management methodologies.
- 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 life cycle 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.
- Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization. Excellent organizational skills and ability to prioritize as well as Project Management abilities.
- 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.