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 Manager, Business Partner and Supplier Quality Assurance in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the R&D Quality team, you will be empowered to execute global pharmacovigilance audit strategy for business partners and global PV System Suppliers in line with Takeda s global pharmacovigilance strategic objectives, and a typical day will include:
- Works with external business partners and suppliers of externalized services to ensure that global pharmacovigilance quality assurance activities at Takeda are conducted per health authority and Takeda requirements
- Support stakeholders in developing and implementing corrective and preventative actions as needed, communicating any critical compliance risks to senior management.
- Executes audit plans for external business partner and global PV System suppliers.
- Maintains risk prioritization tools.
- Supports development of risk-based audit plan for global PV System Suppliers
- Identify compliance issues and conduct investigations for pharmacovigilance activity. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution.
- Ensures contract auditors are and/or maintain the appropriate qualifications.
- Oversees CAPA development, execution, closure and, as needed, escalation for CAPAs associated with stakeholder group.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Minimum BS/BA degree with advanced scientific degree preferred.
- Minimum of 3 years of industry experience in Quality Assurance with focus in GVPs:
- In-depth knowledge of the applicable GVP regulations and ICH Guidelines.
- Pharmacovigilance experience with majority in drug development, biotechnology, device, or related areas.
- Knowledge and understanding of global drug development.
- Experience in operating in a multi-disciplinary drug development environment, including working within and managing across an international exposure.
- Ability to work within complex organizations, working closely with senior staff and executive level colleagues.
- Ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.
- Energetic, smart, and hands-on self-starter with a desire to learn new things quickly. Must be able to exhibit diplomacy with all constituents and represent the changing face of the organization both internally and externally. Demonstrated track record to proactively identify, assess, and analyze scenarios that may affect operations, and a proven history of taking an institutional perspective.
- Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues..
- Excellent communication, interpersonal, and managerial skills. Ability to work independently and collaboratively, strong leadership and organizational skills, and able to drive multiple projects to successful, timely completion in a fast-paced, entrepreneurial environment.
- Outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.
- Ability to use appropriate judgment in maintaining confidentiality of information. Must possess excellent presentation and communication skills, both oral and written. Strong professional writing skills a must.
- Must be able to effectively multi-task, prioritize, meet deadlines, and manage critical issues in a dynamic environment. Ability to manage multiple projects concurrently and manage a large volume of details while maintaining a big-picture perspective.
- Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to effectively present information to top management, internal groups, external stakeholders and customers.
- GVP registration/certification preferred.
- Approximately 20-25% domestic and international 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.