QMS Project Manager -DACH region
About Dot Compliance
Dot Compliance provides a ready-to-deploy, Salesforce-native eQMS with the industry’s first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance.
The company’s solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001.
Who we’re looking for
Dot is a cloud based, innovative software company and our product allows pharma and medical device customers to manage their quality processes electronically, replacing paper-based processes.
We are looking for a Professional Services QMS Project Manager, to join the leadership team of processional services and lead the technical engineers.
Our Product, Dot Compliance Suite, is a leading quality management solution for the life science industry.
As a Project Manager, the candidate will provide project leadership to life science clients embarking on their digital transformation journey.
Our ideal candidate should be familiar with the regulatory requirement and quality processes of life science companies, should have technical orientation, excellent presentation, and training skills and proficient in English.
Responsibilities:
- Work closely with customers to implement our Quality Management solutions and maximize the use of features in alignment with customer requirements.
- Communicate best practices throughout projects to help guide customers.
- Provide training, coaching and mentorship to help customer stakeholders develop their quality management system knowledge.
- Develop and direct work plans, schedules, project estimates, and resource plans.
- Monitor projects from initiation to delivery.
- Provide training, coaching and mentorship to help customer stakeholders develop their quality management system knowledge
Do you have what we’re looking for?
- 5+ years of experience working with or for life sciences companies.
- Background knowledge of quality assurance, and regulatory requirements and processes in the life sciences industry
- Demonstrated knowledge or ability to comprehend document management, training management, audit management, risk management, change management, CAPA management, and Non-Conformance processes.
- BS/BA degree in Science, Engineering or Business Administration OR an equivalent combination of education and work experience
- Excellent verbal and written communication skills in English and German
- Advanced Training Skills
- Experience implementing quality management systems for life sciences- Advantage.
- Demonstrated work history in full life cycle project implementation.