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- Tasks: Lead GPV performance optimization and manage compliance issues in a dynamic pharmaceutical environment.
- Company: Join Kyowa Kirin, a company dedicated to making people smile through innovative healthcare solutions.
- Benefits: Enjoy a hybrid work model and be part of an inclusive culture that values teamwork and innovation.
- Why this job: Make a real impact in healthcare while working with passionate professionals in a supportive environment.
- Qualifications: Strong background in pharmaceutical performance excellence and proven leadership skills required.
- Other info: Kyowa Kirin is committed to equal opportunities and fostering a diverse workplace.
The predicted salary is between 48000 - 72000 £ per year.
Overview
Associate Director GPV Performance Excellence – Optimisation Team
at Kyowa Kirin International plc
Marlow, UK (hybrid)
WE PUSH THE BOUNDARIES OF MEDICINE.
LEAPING FORWARD TO MAKE PEOPLE SMILE
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
Job Purpose:
You will work closely with GPV and cross-functional stakeholders to ensure deviations are appropriately managed, remediated and reported. You will support GPV with audit co-ordination and oversee the management of all PV CAPA arising from audits, deviations, inspections and stand-alone process improvements, ensuring timely verification of actions, long-term effectiveness, as well as strategic remediation of high-level trends and risks.
Responsibilities
Key Responsibilities:
- Ensures GPV deviations are managed well.
- Contributes to the design and implementation of audit preparation.
- Identifies and engages key subject matter experts to participate in audit preparation and management activities.
- Contributes to regular reports to PV leadership on the status of the audit, deviation and inspection outcomes and commitments, escalating issues as required.
- Contributes to late-log reporting interface with GPV Operations sub-function to support with remediation and proactive identification.
- Supports cross-functional GPV interface with Global Audits.
- Maintains an in-depth knowledge of role-relevant electronic systems, i.e. Veeva Quality Documents and global safety related regulations including (but not limited to) EMA, FDA, PMDA, ICH, CIOMS.
- Serves as a strategic thought partner to the Global Head PV Performance Excellence on future strategies of performance optimisation.
Qualifications
Position Requirements:
- Strong experience in pharmaceutical, GCP and/or GVP related performance excellence environment.
- Strong experience of managing people and process management in GCP and/or GVP performance excellence.
- Experience in managing complex organisational compliance issues and in identifying, implementing and leading organisation-wide compliance initiatives.
- Outstanding communication and presentation skills. Proven track record of leadership, accountability, impact, people management and willingness to confront complex problems.
Kyowa Kirin International is an equal opportunities employer.
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Associate Director GPV Performance Optimisation employer: Kyowa Kirin
Contact Detail:
Kyowa Kirin Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director GPV Performance Optimisation
✨Tip Number 1
Familiarize yourself with the specific regulations and guidelines relevant to GPV, such as EMA, FDA, and ICH. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and performance excellence.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience in GCP and GVP environments. Engaging with these individuals can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Prepare to discuss your leadership experiences in managing complex compliance issues. Be ready to share specific examples of how you've successfully navigated challenges and implemented effective solutions in previous roles.
✨Tip Number 4
Showcase your communication and presentation skills during the interview process. Practice articulating your thoughts clearly and confidently, as these skills are crucial for collaborating with cross-functional teams and presenting to leadership.
We think you need these skills to ace Associate Director GPV Performance Optimisation
Some tips for your application 🫡
Understand the Company Culture: Familiarize yourself with Kyowa Kirin International's values: Teamwork, Commitment to Life, Innovation, and Integrity. Reflect these values in your application to show that you align with their mission of making a difference.
Highlight Relevant Experience: Emphasize your strong experience in pharmaceutical environments, particularly in GCP and GVP performance excellence. Provide specific examples of how you've managed compliance issues and led initiatives in your previous roles.
Showcase Communication Skills: Since outstanding communication and presentation skills are crucial for this role, include examples of how you've effectively communicated complex information or led presentations in your past positions.
Tailor Your Application: Customize your CV and cover letter to reflect the key responsibilities and qualifications mentioned in the job description. Make sure to address how you can contribute to audit preparation and management activities.
How to prepare for a job interview at Kyowa Kirin
✨Understand the Company Culture
Familiarize yourself with Kyowa Kirin's values: Teamwork, Commitment to Life, Innovation, and Integrity. Be prepared to discuss how your personal values align with theirs and provide examples of how you've embodied these principles in your previous roles.
✨Showcase Your Experience
Highlight your strong experience in pharmaceutical performance excellence, particularly in GCP and GVP environments. Prepare specific examples of how you've managed compliance issues and led initiatives that resulted in significant improvements.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to manage complex situations. Think of scenarios where you successfully navigated challenges in audit preparation or compliance management, and be ready to share those stories.
✨Demonstrate Communication Skills
Since outstanding communication is crucial for this role, practice articulating your thoughts clearly and confidently. Be prepared to present your ideas on performance optimization strategies and how you would engage with cross-functional teams effectively.
