Software Compliance and Validation Manager
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Image Analysis Group (IAG) is an expert medical imaging company that has grown to become a global leader in clinical research, which involves medical imaging (MRI, CT, Xray) to measure efficacy and safety of new drugs.
We provide the cloud based image management platform (DYNAMIKA) and R&D services to support pharmaceutical companies developing new drugs. DYNAMIKA supports imaging data logistics in a multi-centre trial setting, automates many labour intense routines (quality checks, DICOM header checks, anonymization) and speeds up the imaging data analysis with AI driven methodologies. We have released the 3rd generation platform (GCP and Microservices) and it has become the software of choice for many biotech and pharma companies around the world.
We are looking for a Software Compliance and Validation Manager to establish a framework for GxP validation within the current system development lifecycle (taking into consideration agile/hybrid methodology) and implement changes to standard operating procedures (SOP’s) and policies.
Drive the compliance culture throughout the organization by ensuring adequate training of all employees and appropriate level of understanding regarding compliance with 21 CFR Part 11, EU Annex 11 etc.
Develop validation documents supporting GxP compliance, including validation and testing plans, qualification plans, data integrity assessments, gap analysis, risk analysis, failure mode and effect analysis (FMEA), traceability matrices.
Prepare summary reports, deficiency reports.
Input into System Design Specifications (SDS), Users Requirements Specifications (URS), and Detailed Design Specifications (DDS) to ensure GxP and regulatory expectations are incorporated into the system.
Participate in both inspections and audits as a GxP validation subject matter expert.
Maintain efficient archives of all validation documentation and supporting evidence for review during client audits and regulatory inspections.
- Experience in Software Quality Assurance and Computer System Validation and Requirements Analysis.
- Familiar with Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies and frameworks.
- Knowledge of Regulatory Procedures FDA 21 CFR Part 11, Part 820, and ISO13485 with good understanding of GxP related processes including risk-based approach and validation.
- Ability to deliver training.
- Adherence to policies and procedures to ensure quality of service and compliance with regulatory requirements.
- Ability to engage, interact, and negotiate effectively with other stakeholders.
- Knowledge of the business enterprise functions and processes.
- Good analytical and problem-solving skills.
- Ability to adapt to a fast and dynamic environment, changes in workload, staffing and scheduling.
- Hands-on approach.
- Ability to effectively translate between functional and technical teams.
- Excellent written, oral, and interpersonal communication skills.
- Highly self-motivated, self-directed, and attentive to detail.
- Ability to communicate effectively with management.
- 7 -10+ years’ experience working in a management/strategic decision-making role related to compliance and validation of computer systems within an FDA regulated environment, or within a provider whose services / products target FDA regulated companies and whose services / products must be able to be validated to be compliant with 21CFR Part 11.
- Expert knowledge of Computer Systems Validation in a life science or regulated environment required.
- Experience with software validation and testing methodologies, documentation and product specifications in an FDA regulated environment such as pharmaceutical, bio-tech or medical device required.
- Knowledgeable in all of the following regulations/regulatory guidelines: 21 CFR Part 11, Electronic Records – Electronic Signatures; General Principles of Software Validation – Final Guidance for Industry and FDA Staff; Good Automated Manufacturing Practices (GAMP) guidelines; or other methodologies for Computer Systems Validation in a regulated environment.
- BA/BS degree in a technical field, or equivalent education and experience.
- Must be proficient with Microsoft Office applications and Adobe Acrobat
- Experience with automated systems for following activities/functions is helpful:
- Document management (EDMS, Dropbox/SharePoint)
- Requirements and Testing (JIRA/Zephyr)
- ISTQB (Foundation and Agile Tester) certification
What we offer:
- Competitive salary
- Quarterly individual performance and company performance driven bonus
- Equity stake in a rapidly growing company for qualified team who are making visible impact on the company’s growth
- Huge room for progression – get in on the ground floor of the next big star-tup
- A remote software development environment (one office day per 2 weeks for meetings & catchups)
- Opportunities for international travel if desired; continuous learning
No recruitment agencies or contractors at this time please.
- 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