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- Tasks: Lead quality assurance initiatives and optimise audit processes in a dynamic healthcare environment.
- Company: Join PrimeVigilance, a global leader in pharmacovigilance with a focus on employee well-being.
- Benefits: Enjoy training opportunities, career development, and a supportive work culture.
- Why this job: Make a real impact on patient lives while working with a diverse, global team.
- Qualifications: Degree in healthcare or related field; experience in pharmacovigilance and quality management.
- Other info: Embrace a culture of diversity, equity, and inclusion in a collaborative workplace.
The predicted salary is between 43200 - 72000 £ per year.
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We cover services within Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance, with staff based across Europe, North America and Asia. PrimeVigilance provides first class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and covering all therapy areas including medical device. We invest in our staff with training and development, value employee experience, well-being and work-life balance, and aim to deliver high-quality client service. This role is part of an exciting journey to make a positive impact in patient lives.
Role and 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.
- Monitors and communicates trends seen in audits and Inspections to the Director of Quality Assurance.
- Proactively prepares the company and clients for regulatory inspections and audits.
- 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 changes with the relevant IT SME to EG-QMS.
- 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 applicable laws and regulations including EU GVP, US FDA CFRs, JMPA and ICH-E6.
- Conducts other ad hoc activities as requested by the 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. Our people are our greatest strength in improving the lives of those around us.
Benefits and Opportunities
- 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.
Core Values
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
Associate Director Quality Assurance (hybrid in Europe- onsite when needed for audits and inspe[...] in Guildford employer: Ergomed
Contact Detail:
Ergomed Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Quality Assurance (hybrid in Europe- onsite when needed for audits and inspe[...] 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. Understand their values and how they align with yours. We want you to show up not just as a candidate, but as someone who genuinely fits into their team and mission.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. We believe that being well-prepared can make all the difference when it comes to impressing your interviewers.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in leaving a positive impression. We recommend expressing your appreciation for the opportunity and reiterating your enthusiasm for the role.
We think you need these skills to ace Associate Director Quality Assurance (hybrid in Europe- onsite when needed for audits and inspe[...] in Guildford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Director Quality Assurance role. Highlight your experience in pharmacovigilance and quality management, and don’t forget to showcase any relevant audits or inspections you've been involved in.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how your skills align with our mission at PrimeVigilance. Keep it concise but impactful!
Showcase Your Soft Skills: We value strong communication and interpersonal skills, so make sure to highlight these in your application. Share examples of how you've led teams or facilitated discussions in previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity with PrimeVigilance!
How to prepare for a job interview at Ergomed
✨Know Your Regulations
Make sure you brush up on your knowledge of international regulations related to pharmacovigilance and medical information. Being able to discuss GVP, GCP, and other relevant guidelines confidently will show that you're not just familiar with the field but also serious about quality assurance.
✨Showcase Your Experience
Prepare specific examples from your past experiences where you've participated in audits and inspections. Highlight your role in these processes and any improvements you implemented. This will demonstrate your hands-on experience and problem-solving skills, which are crucial for this position.
✨Communicate Effectively
Since excellent communication is key in this role, practice articulating your thoughts clearly and concisely. Be ready to explain complex concepts in a way that's easy to understand, as you'll need to collaborate with various teams and stakeholders.
✨Emphasise Team Leadership
Be prepared to discuss your leadership style and how you've mentored or developed teams in the past. This role involves managing the audit and inspection hosting team, so showcasing your ability to lead and foster a culture of quality will be essential.
