GVP Inspection Readiness - Associate Director応募後で応募 求人ID R0035329 掲載日 06/15/2021 Location:Zurich, Switzerland; Boston, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Associate Director, GVP Inspection Readiness at our Zurich location.
Here, you will be a vital contributor to our inspiring, bold mission.
In this role, you will contribute to Takeda’s mission by having the ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy. A typical day will include:
Directs inspection readiness activities, enabling proactive inspection readiness across the entire Pharmacovigilance (PV) System and supports inspections where GSPE is a stakeholder, i.e. GMP/GCP.
Execute inspection strategy for the PV System, using the framework provided by R&D Quality Compliance and Systems and directs inspection planning across PV System leading ongoing efforts to maintain a steady state of inspection readiness.
Directs inspection readiness activities including reporting and escalating inspection risks along with development and execution of mitigation actions focused on risk mitigation.
Leads on site business PV partner audits.
Collaborate with GPSE QA Inspection readiness leadership in cascading messages and goals from senior management and leading the management & prioritization of team workload.
Lead PV inspection readiness activities 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 and sustainable actions to address the issue.
Manage Quality Contact assignment for CAPAs owned by stakeholders. This role could also act as the Quality Contact.
Assist with the development and execute the strategy to understand health of the PV System, e.g. risk register, KPIs.
Influences stakeholders to drive timely action where risk mitigation is required.
Partners with stakeholders to drive improvement to the inspection and business partner audits related to the PV System.
Co-host along with Head of Inspection Readiness, regulatory inspections, as necessary, and manage responses to regulatory agency questions resulting from these inspections.
Leads preparation, support and follow-up activities for onsite business partner audits.
Host audits from business partners conducted on site.
EDUCATION, EXPERIENCE AND SKILLS:
Education & Experience
Bachelor’s Degree required; Advanced Degree preferred.
Minimum 8 years of increasing responsibility in pharmaceutical, GVP and/or related Quality environment.
Minimum 5 years of people and/or process management experience in GVP and/or Quality Assurance including senior level project management.
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 - Expert knowledge of global GVP regulations and guidance; Understands the regulatory environment for global pharmaceutical companies, as well as best practices in the Pharma industry to satisfy regulatory requirements.
Industry Knowledge – Strong working knowledge of the pharmaceutical industry and the PV legislation (preferably EMA, FDA, MHRA, PMDA and HC).
Demonstrates advanced knowledge in the conduct and reporting of audits and investigations, as well as the translation of findings into corrective actions 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.
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.
Personnel Management Knowledge – Proficient in managing large teams, and in providing coaching and mentoring to employees.
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 or Black Belt preferred.
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Carrying, handling and reaching for objects.
Position located in Zurich, Switzerland or Cambridge, MA
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel will be required.
25% travel required.
WHAT TAKEDA CAN OFFER YOU
- Excellent conditions & benefits including generous holidays
- Genuine career progression and development
- Opportunity to work with a world class leader in the pharmaceutical sector
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People to Shine