Project Document Manager (PCM) Lead (a), 100% — Bachem AG

Full description

In order to drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our team in the Global Engineering department, we are looking for a dedicated Project Document Manager (PCM) Lead (a), 100%.

Their tasks

• Establishment, maintenance and control of the project-wide document management system (DMS) in an assigned project
• Definition and monitoring of document standards, templates and workflows
• Ensuring compliance with GMP, GxP, 21 CFR Part 11 and internal SOPs
• Management of document life cycles (creation, review, approval, archiving)
• Responsibility for project governance in medium and large projects, including the definition, implementation and further development of standards, processes and quality guidelines.
• Management and coordination of internal and external employees in the area of project documentation, including distribution of tasks, quality assurance and professional guidance.
• Ensure uniform, complete and audit-proof project documentation across all project phases.
• Establishing and maintaining a clear filing structure, versioning and approval processes in cooperation with the PMO.
• Conduct regular reviews, training sessions and feedback rounds to continuously improve documentation quality.
• Promote an efficient, transparent and collaborative way of working among all stakeholders.
• Support of project management in reporting, risk and change management, especially with regard to documentation-relevant aspects.
• Close cooperation with engineering, quality assurance, validation, production and external suppliers. Clarify tasks and responsibilities and ensure a consistent approach.
• Support for the departments in the preparation and structuring of technical documents
• Training of project staff in handling the DMS and documentation guidelines
• Preparation and support for internal and external audits
• Ensuring traceability of all project-critical documents and compliance with SOPs
• Identification of potential improvements in the document flow
• Implementation of efficient document processes and digital tools
• Monitoring of KPIs (e.g. lead times, number of open reviews)
• Perspectively, it is possible to take over the management of the Project Management Office (PMO) in medium-sized and large projects.

Your profile

• Completed studies (e.g. life sciences, quality management, documentation management, engineering) or comparable qualification
• Several years of experience in document management, ideally in the pharmaceutical or biotech industry
• In-depth knowledge of regulatory requirements (GMP, GxP, Annex 11, 21 CFR Part 11)
• Experience with DMS systems (e.g. Veeva, Documentum, OpenText, SharePoint)
• High level of detail and structured working methods
• Strong communication and moderation capabilities
• Ability to understand and organize complex technical content
• Proactive, solution-oriented thinking
• Resilience and organisational talent in dynamic project environments

Our offer

• A dynamic and rapidly growing working environment with internal development and further education opportunities
• Flexible working hours with the option of home office and the option to purchase additional holidays with reduced workload
• Company-internal KITA on the Bachem Campus Bubendorf
• 60% takeover of pension fund contributions by Bachem AG as well as possibility for over-compulsory provision with our elective savings plan
• Access to advantage platforms with discounts from external partners
• Fresh, healthy and diverse food in our staff restaurant
• Various free sports activities on the Bachem Campus

Do you want to drive innovation together with us?

Have we aroused your interest? Then we look forward to your complete application documents via our application portal.

Learn more about the Bachem Group and be inspired by our inspiring working environment at our location in Bubendorf!