QMS Project Manager

🔥 8 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👷‍♀️ Project Manager

👻 Ghost score 10%

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Dot Compliance

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 $17.5M Series B on 2024-04

Healthcare • Consulting • Biotechnology

Dot Compliance is an industry leader in developing AI-powered electronic Quality Management Systems (eQMS) tailored for the life sciences sector, including pharmaceutical, biotechnology, and medical device industries. Their platform simplifies and accelerates compliance and quality management processes, enabling organizations to innovate faster while ensuring regulatory adherence. With a focus on efficient document management, change management, and risk management, Dot Compliance utilizes advanced AI technology to provide actionable insights for quality assurance and operational excellence.

📋 Description

• Lead customer implementation projects end to end, keeping scope, timelines, and quality objectives on track • Lead discovery workshops to map current-state quality processes, capture requirements, and define target configuration • Partner with customers to configure and optimize Dot Compliance solutions around business and compliance requirements • Share best practices and provide strategic guidance across the full project lifecycle • Run training sessions, workshops, and ongoing coaching to build customer quality management capability • Drive user adoption and change readiness, including building and coaching customer super-user and champion networks • Build and maintain detailed work plans, schedules, estimates, and resource allocations • Track progress, surface risks early, and drive proactive mitigation • Manage multi-site and multi-country rollouts across regions and time zones • Coordinate internal consultants, technical/Salesforce, Support, and R&D resources, and manage handover to Customer Success after go-live • Use AI-powered tools to accelerate project plans, configuration documentation, and training materials while maintaining accuracy, quality, and compliance • Act as a trusted advisor and build long-term customer relationships • Identify opportunities for additional services and module expansion with Customer Success and Sales • Contribute to continuous improvement of implementation methodology, templates, and accelerators

🎯 Requirements

• 7+ years in professional services, Customer Success, or project management within the life sciences sector • Strong grasp of regulatory requirements and quality processes across pharma, biotech, and/or medical devices • Knowledge of ISO 13485, FDA 21 CFR Part 11, 21 CFR Part 820 (QMSR), EU MDR, GxP, and EU GMP Annex 11 • Experience with eQMS implementation, preferably on Salesforce-based platforms • Demonstrated ability to manage complex projects and lead cross-functional teams • Bachelor’s degree in science, Engineering, Business Administration, or a related field, or equivalent professional experience • Excellent written and verbal communication in English • Strong problem-solving, organizational, and stakeholder management skills • Experience with Dot Compliance or similar cloud-based QMS platforms is a bonus • Familiarity with Salesforce CRM or Force.com platform is a bonus • PMP, PRINCE2, or equivalent project management certification is a bonus • German or French is a plus

🏖️ Benefits

• Full-time employment • Remote work arrangement

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