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, Good Pharmacovigilance Practices GVP Inspection Readiness 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 Assurance team, you will be empowered to work with stakeholders on inspection readiness activities, enabling proactive inspection readiness across the entire PV System and supports GSPE for non-GVP inspections, i.e. GMP/GCP , and a typical day will include:
- Supports inspection strategy for the PV System, using the framework provided by R&D Quality Compliance and Systems and assures inspection planning across PV System enabling ongoing efforts to maintain a steady state of inspection readiness. Escalates challenges to senior leadership when challenges present themselves during execution of the plan.
- Identifies risks within the PV System and works with stakeholders in developing mitigation/remediation activities.
- Host on site business partner audits.
- Works with GPSE QA Inspection readiness leadership in cascading messages and goals from senior management.
- Contributes to list of inspections confirmed and projected
- Works with leadership during inspections to organize site departments, coach subject matter experts, or interface with inspectors.
- Lead inspection response activities ensuring stakeholders identify appropriate root cause of the finding and develop achievable actions, this includes as needed, effectiveness checks to ensure that the actions taken are sustainable, i.e. chances of recurrence are minimized or eliminated.
- Act as Quality Contact for CAPAs owned by stakeholders
- Executes the strategy to understand health of the PV System, e.g. risk register, KPIs
- Partner with R&D Quality Compliance and Systems and stakeholders for internal audits related to PV System
- Host audits from business partners conducted on site
EDUCATION, EXPERIENCE AND SKILLS:
Education & Experience
- Bachelor s Degree required; Advanced Degree preferred.
- Minimum 5 years of increasing responsibility in pharmaceutical, GCP- and/or GVP related Quality environment.
- Minimum 3 years of people and/or process management experience in GCP and/or GVP Quality Assurance
- Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives
- Skilled in managing global, cross-functional projects
- Regulatory Knowledge - Knowledge of global GVP regulations and guidances; good working knowledge of global GCP, GMP and GLP regulations and guidances. Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements.
- Industry Knowledge Working knowledge of the pharmaceutical industry and the new drug development process; understands the phases, processes and techniques used in the science of pharmacovigilance.
- Knowledge in the conduct and reporting of audits and investigations, as well as the translation of findings into corrective action plans that mitigate risks to the company, to safety and data integrity.
- In-depth understanding of the good practices for the creation and management of a Quality Management System.
- Scientific Knowledge - Possesses the necessary science education and knowledge to provide Quality Assurance oversight.
- Communication Skills - Must professionally, clearly, concisely and consistently communicate to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills.
- Negotiation Skills - Demonstrates proficiency in negotiation and conflict resolution.
- Project Management - Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
- Organizational Skills - Must be able to prioritize work effectively to meet timelines, and delegate to subordinates.
- Interpersonal - Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
- Computer skills - Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
- ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional or equivalent preferred.
- Six Sigma Green Belt preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Position is located in Metro Boston Area (MA, US).
- Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel will be required.
- Requires approximately 25 % 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.