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- Tasks: Lead quality assurance initiatives and optimise audit processes in a dynamic environment.
- Company: Join a global leader in pharmaceutical quality management with a focus on collaboration.
- Benefits: Enjoy career development, a supportive culture, and the chance to work globally.
- Why this job: Make a real impact on healthcare quality while growing your skills and career.
- Qualifications: Degree in healthcare or science, with experience in pharmacovigilance and quality assurance.
- Other info: Diversity and inclusion are at our core; we value every voice in our team.
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.
Responsibilities:
- Works with the Director of Quality Assurance to drive excellence and optimize audit and inspection hosting.
- Participate 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.
- Works with the Quality Assurance Manager to continually develop and maintain training material for audit & inspection attendees.
- Monitors and communicates trends seen in audits and inspections to the Director of Quality Assurance.
- Works with the hosting team to develop and maintain an inspection knowledge library.
- 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, identifying process improvements and initiating 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.
- Manages the audit and inspection hosting team.
- 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 prioritize 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.
Benefits:
- 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 (Europe- hybrid/remote)- Line Management and Audit Hosting[...] in Guildford employer: PrimeVigilance
Contact Detail:
PrimeVigilance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Quality Assurance (Europe- hybrid/remote)- Line Management and Audit Hosting[...] in Guildford
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and tailoring your answers to highlight your experience in quality assurance and compliance. Show them you’re the perfect fit for their team!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to remind them why you’re the right choice for the Associate Director role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Associate Director Quality Assurance (Europe- hybrid/remote)- Line Management and Audit Hosting[...] 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, so don’t hold back on showcasing your relevant achievements!
Showcase Your Communication Skills: Since this role involves a lot of collaboration and training, it’s essential to demonstrate your excellent communication abilities. Use examples from your past experiences where you’ve effectively communicated complex information or led training sessions.
Highlight Your Problem-Solving Skills: We love candidates who can think on their feet! Share specific instances where you identified issues and implemented solutions, especially in audit or inspection contexts. This will show us that you’re proactive and ready to tackle challenges head-on.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company culture and values.
How to prepare for a job interview at PrimeVigilance
✨Know Your Quality Assurance Basics
Make sure you brush up on your knowledge of GVP and GCP-related Quality Management. Be ready to discuss how these principles apply to audits and inspections, as well as any relevant regulations. This will show that you’re not just familiar with the terms but can also apply them in real-world scenarios.
✨Showcase Your Leadership Skills
Since this role involves managing a team, be prepared to share examples of how you've led and developed teams in the past. Highlight your mentoring experiences and how you’ve fostered a culture of quality within your previous organisations. This will demonstrate your capability to drive excellence in audit hosting.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific audit situations or compliance challenges. Think through potential scenarios and prepare structured responses that showcase your problem-solving skills and decision-making abilities. Use the STAR method (Situation, Task, Action, Result) to frame your answers.
✨Communicate Effectively
Strong communication is key in this role, so practice articulating your thoughts clearly and confidently. Be ready to discuss how you’ve effectively communicated audit results and compliance guidance in the past. This will help convey your ability to collaborate with operational personnel and ensure effective audit attendance.