QMS Project Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee customer implementation projects from start to finish, ensuring adherence to scope, timelines, and quality standards.

• Facilitate discovery workshops to assess current-state quality processes, gather requirements, and establish target configurations.

• Collaborate with customers to tailor and enhance Dot Compliance solutions in alignment with business and compliance needs.

• Share industry best practices and offer strategic insights throughout the entire project lifecycle.

• Conduct training sessions, workshops, and continuous coaching to enhance customer quality management capabilities.

• Promote user adoption and readiness for change, including developing and mentoring customer super-users and champion networks.

• Create and sustain comprehensive work plans, schedules, estimates, and resource allocations.

• Monitor progress, identify risks early on, and implement proactive mitigation strategies.

• Manage the execution of multi-site and multi-country rollouts across various regions and time zones.

• Coordinate with internal consultants, technical/Salesforce teams, Support, and R&D resources, ensuring a smooth transition to Customer Success post go-live.

• Utilize AI-driven tools to expedite project plans, configuration documentation, and training materials while ensuring accuracy, quality, and compliance.

• Serve as a trusted advisor to foster long-term customer relationships.

• Spot opportunities for additional services and module expansion in collaboration with Customer Success and Sales.

• Contribute to the ongoing enhancement of implementation methodologies, templates, and accelerators.

⛳️ Requirements

• 7+ years of experience in professional services, Customer Success, or project management within the life sciences industry.

• In-depth understanding of regulatory requirements and quality processes in pharmaceuticals, biotechnology, and/or medical devices.

• Familiarity with ISO 13485, FDA 21 CFR Part 11, 21 CFR Part 820 (QMSR), EU MDR, GxP, and EU GMP Annex 11.

• Background in eQMS implementation, preferably on Salesforce-based platforms.

• Proven track record of managing complex projects and leading cross-functional teams.

• Bachelor’s degree in science, engineering, business administration, or a related field, or equivalent professional experience.

• Exceptional written and verbal communication skills in English.

• Strong problem-solving, organizational, and stakeholder management capabilities.

• Experience with Dot Compliance or comparable cloud-based QMS platforms is an advantage.

• Knowledge of Salesforce CRM or the Force.com platform is an asset.

• PMP, PRINCE2, or similar project management certification is a plus.

• Proficiency in German or French is advantageous.

🏝️ Benefits

• Full-time employment.

• Remote work arrangement.