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- Tasks: Lead quality assurance initiatives and manage audits to ensure compliance and continuous improvement.
- Company: Join a diverse and inclusive company dedicated to improving lives through quality assurance.
- Benefits: Career development, supportive environment, and global collaboration opportunities.
- Why this job: Make a real impact in the pharmaceutical industry while growing your skills and expertise.
- Qualifications: Degree in healthcare or science, with experience in pharmacovigilance and quality management.
- Other info: Embrace a culture of quality and teamwork in a dynamic, global setting.
The predicted salary is between 36000 - 60000 £ per year.
The Associate Director of Quality Assurance ensures continuous quality improvement through effective management and oversight of audits and inspections. Identifies and implements IT solutions and process efficiencies. Facilitates ongoing quality improvement measures through communication of audit inspection intelligence, analytics reports and compliance guidance/training. Drives ongoing quality improvement initiatives by disseminating audit and inspection intelligence, delivering comprehensive analytics reports, and providing expert compliance guidance and training. Leads the audit and inspection hosting team. As a leader, cultivates a high-performing team, fostering their development into subject matter experts through education, mentorship, and empowerment.
Role and Responsibilities
- Works with the Director of Quality Assurance to drive excellence and optimize audit and inspection hosting.
- Participates in audits and inspections, including document request provision, front and back-room activities, and follow-up of audit and inspection findings and completion of client questionnaires and RFP/RFI when needed.
- Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
- Identifies and implements process improvements and efficiencies via IT solutions.
- Works with the Quality Assurance Manager to develop and train the hosting team in all activities associated with hosting.
- Continually develops and maintains training material for audit inspection attendees.
- Monitors and communicates trends seen in audits and inspections to the Director of Quality Assurance.
- Develops and maintains an inspection knowledge library with the hosting team.
- Proactively prepares the company and clients for regulatory inspections and audits.
- Collaborates and guides operational personnel to ensure effective audit and inspection attendance.
- Generates metrics on audits and inspections for Global Quality Council, Quality Leadership, Senior Leadership, and Management review purposes.
- Manages the electronic quality management system (EG-QMS) Audits module.
- Identifies process improvements and initiates these changes with the relevant IT SME to EG-QMS.
- Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.
- Acts as a Subject Matter Expert and client point-of-contact for Quality including attendance at operational and quality governance meetings.
- Assists in the development, maintenance and management of mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, US FDA CFRs, JMPA and ICH-E6.
- Conducts other ad hoc activities as requested by Director of Quality Assurance and/or VP of Quality.
Qualifications
- A university degree in a healthcare discipline or equivalent scientific area.
- Substantial experience in pharmaceutical/biotechnology pharmacovigilance with an in-depth understanding of GVP/GCP-related Quality Management and Assurance.
- Sound knowledge of international regulations related to Pharmacovigilance and Medical Information.
- Significant experience of participating in audits and inspections.
- Excellent communication and facilitation skills within a global organization.
- Proactive and self-motivated.
SPECIAL SKILLS
- Strong organizational and planning abilities.
- Excellent problem-solving and decision-making skills.
- Ability to lead, mentor, and develop teams.
- Strong communication and interpersonal skills.
- Attention to detail and commitment to high standards.
- Ability to analyze data and prepare detailed reports.
- Knowledge of quality management principles and practices.
Additional Information
We prioritise diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- Training and career development opportunities internally.
- Strong emphasis on personal and professional growth.
- Friendly, supportive working environment.
- Opportunity to work with colleagues based all over the world, with English as the company language.
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join:
- Quality
- Integrity
- Trust
- Drive
- Passion
- Agility
- Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
Associate Director Quality Assurance in Guildford employer: PrimeVigilance
Contact Detail:
PrimeVigilance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Quality Assurance in Guildford
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage on platforms like LinkedIn. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with yours. We want you to show them you’re not just a fit for the role, but for the team too!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality assurance and compliance. We recommend using the STAR method (Situation, Task, Action, Result) to structure your answers effectively.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can leave a lasting impression. We believe it shows your enthusiasm and professionalism, which can set you apart from other candidates.
We think you need these skills to ace Associate Director Quality Assurance in Guildford
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in quality assurance and audits. We want to see how your skills align with the role of Associate Director Quality Assurance, so don’t hold back on showcasing your relevant achievements!
Showcase Your Leadership Skills: As a potential leader in our team, it’s important to demonstrate your ability to mentor and develop others. Share examples of how you've cultivated high-performing teams in the past, as this will resonate well with us at StudySmarter.
Be Clear and Concise: When writing your application, clarity is key! Use straightforward language and structure your thoughts logically. This not only makes it easier for us to read but also reflects your communication skills, which are crucial for this role.
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen to join our community!
How to prepare for a job interview at PrimeVigilance
✨Know Your Quality Assurance Fundamentals
Make sure you brush up on your knowledge of GVP and GCP-related Quality Management and Assurance. Be ready to discuss how these principles apply to the role and share examples from your past experiences that demonstrate your understanding.
✨Showcase Your Leadership Skills
As an Associate Director, you'll be leading a team. Prepare to talk about your leadership style and provide specific examples of how you've mentored or developed team members in the past. Highlight any successful initiatives you've led that improved quality or efficiency.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities. Think of scenarios where you've had to handle audits or inspections, and be ready to explain your thought process and the outcomes. This will show your analytical skills and attention to detail.
✨Communicate Effectively
Strong communication is key in this role. Practice articulating your thoughts clearly and concisely. Be prepared to discuss how you would communicate audit results and compliance guidance to various stakeholders, ensuring everyone understands their roles in quality improvement.
