Location: HQ: London, UK / Location is Flexible
Salary: negotiable, depending on experience + bonus
How to Apply: Email your CV and Cover Letter: <Michael.Clark @ ia-grp.com >, Subject: Quality Assurance Manager – CFR21 part 11
IAG, IMAGE ANALYSIS GROUP is a fast-growing medical imaging expert organization that supports pharmaceutical companies in developing new treatments to improve patients’ lives. We strategically use medical imaging, such as MRI, CT, and PET to accelerate drug development and lower investment risks. Our Quality Management System (QMS) and Standard Operating Procedure (SOPs) are developed to support efficient delivery of imaging services, imaging data management and image review. As part of our services, we provide DYNAMIKA, IAG’s property cloud-based platform for central collection and review of the imaging data.
We are currently seeking an experienced Quality Manager, who is looking for an exciting and challenging career within clinical research sector.
We are looking for a person who can translate IAG’s management objectives into the quality targets while encouraging and training the team. You must be people and client focused, while incredibly organized and process driven. In this role, you will be leading the development and improvement of IAG’s quality management system. You will be managing customer expectations and leading quality audits. The person in this position is also responsible to structure and develop the QA team in support of business growth while creating a culture where everyone owns quality.
WHAT YOU’LL BE DOING:
QMS & STRATEGY
- Align quality objectives with IAG’s growth and IAG’s management plans.
- Develop outstanding processes for clinical trial delivery.
- Update and improve outdated processes and SOPs.
- Develop processes and KPIs to efficiently manage IAG’s quality and compliance.
- Ensure that QMS and IAG are compliant with all recent regulations and clients’ expectations.
- Take full accountability for maintaining, updating and managing Quality Management System (QMS) and training the team.
- Set appropriate metrics and reports metrics to update the management team.
- Ensure that the delivery of clinical trials and development of our software are compliant with QMS and all legal requirements.
- Report to the management any non-compliance.
- Develop risk and mitigation plans.
- Preform gap analysis and assess the current QMS which incorporates GCP, 21-CFR Part 11.
- Design, develop, implement, and assist in management of all quality assurance programs by identifying and implementing process enhancements to IAG’s quality systems and processes through appropriate stakeholders.
- Work directly with IAG’s development and operations teams to ensure the accuracy and consistency of system development and validation deliverables.
- Facilitate quality training of peers on quality related matters as needed.
- Plan improvement of the processes to ensure IAG’s team effectiveness and clients’ satisfaction.
- Take full responsibility over internal and external audits.
- Act as a quality representative for third parties.
- Manage all aspects of audits / audit conduct. Support all audit / inspection types (e.g. internal, external, vendor, regulatory inspections).
- Plan, conduct, and report audits’ findings according to IAG’s standard operating procedures.
- Track audit issues and/or CAPAs until closure.
- Bachelor’s degree in a relevant subject or comparable proven experience in a QA Management role.
- 3+ years of relevant experience in a Quality Management role in regulated environment (21 CFR part 11, ISO)
- Experience in working within clinical research (CRO, biotech or pharma).
- Imaging CRO and imaging device experience would be a plus.
- Strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, GDPR.
- Proven competency with developing and maintaining quality management systems (QMS).
- Knowledge of 21-CFR Part 11.
- Hands on experience in supporting audits.
- Understanding of medical and/or clinical trial terminology is desirable
- Software Validation requirements and knowledge of ISO13485 standard would be a plus.
- Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
What is our culture?
We are not a firm that works 9 to 5, punching the clock. Instead, we have a high-performance culture that rewards creative solutions to daily challenges, as well as a strong work ethic. We certainly work hard and are all in the office between 8:30 and 6:00 pm daily unless traveling. Going back online after dinner is common to get our jobs done. We make sure that each person is aware of the bigger picture and knows how he or she contributes to the overall business growth. Each team member is regularly appraised and rewarded through a bonus system when the company is doing well.
What we offer:
- Career development opportunities from conferences to self-guided learning, we will support your special interests and professional growth.
- Influence across a growing global organisation.
- A friendly, supported work environment.
- Pension contribution.
- Quarterly bonus.
- Our recruitment process is rigorous but friendly. Our face to face interviews (currently via Teams!) are designed to help you tell us what you know, and what you enjoy. Hopefully, some of the team will drop by to listen in on some of this, giving you both an opportunity to meet
- We strive to be a welcoming and supportive IAG. We recognise the real value a diverse and inclusive workplace brings, and we welcome applicants from all backgrounds
- Visa sponsorship is not available at this time.
Email your cv to michael.clark@localhost
IAG, Image Analysis Group, is a fast-growing digital imaging and technology company serving biotech and pharmaceutical clients. IAG team provides imaging expertise, technology and operational support to clients developing novel therapeutics using medical imaging-based markers in multi-centre trials. IAG’s foundation is in software development, AI and computer science applied to medical image analysis. Today IAG’s team is a blend of technologists, computer scientists, radiologists and medical experts in drug trial development and trial delivery. We created our cloud platform DYNAMIKA, which now incorporates novel image analysis approaches which we are taking commercially and actively using in clinical trials supporting our clients’ drug development. We are here to bring the new thinking into the clinical development while acknowledging the power of state-of-the-art methods. We believe that to be successful in developing an advance therapy or addressing precision medicine concept, we need to work with best available imaging (MR, CT, PET) and the best possible image processing techniques. You can read more about our partnerships and projects here: https://www.ia-grp.com/trial-solutions/bio-partnering/