Project Document Manager (PCM) Lead (a), 100%

Project Document Manager (PCM) Lead (a), 100% # Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. To drive our continuous organic growth, we are constantly looking for highly qualified specialists. To strengthen our team in the Global Engineering department, we are looking for a committed Project Document Manager (PCM) Lead (a), 100%.   Your tasks: • Setup, 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 lifecycles (creation, review, release, archiving) • Responsibility for project governance in medium-sized and large projects, including definition, implementation and further development of standards, processes and quality guidelines. • Leadership and coordination of internal as well as external employees in the area of project documentation, including task distribution, quality assurance and technical guidance. • Ensuring uniform, complete and audit-proof project documentation across all project phases. • Establishment and maintenance of a clear filing structure, versioning and release processes in cooperation with the PMO. • Conducting regular reviews, training sessions and feedback rounds for the continuous improvement of documentation quality. • Promotion of an efficient, transparent and collaborative way of working between all involved 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. Clarification of tasks and responsibilities, as well as ensuring a uniform approach. • Support of specialist departments in the creation and structuring of technical documents • Training of project employees in the use of the DMS and documentation guidelines • Preparation and support during internal and external audits • Ensuring the traceability of all project-critical documents and compliance with the SOPs • Identification of improvement potential in the document flow • Implementation of efficient document processes and digital tools • Monitoring of KPIs (e.g. lead times, number of open reviews) • Prospectively, there is the possibility to take over the leadership 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 pharma or biotech industry • Profound knowledge of regulatory requirements (GMP, GxP, Annex 11, 21 CFR Part 11) • Experience with DMS systems (e.g. Veeva, Documentum, OpenText, SharePoint) • High attention to detail and a structured way of working • Strong communication and moderation skills • Ability to understand and organize complex technical content • Proactive, solution-oriented mindset • Resilience and organizational talent in dynamic project environments   Our offer: • A dynamic and strongly growing work environment with internal development and further training opportunities • Flexible working hours with the possibility for home office and the option to take additional vacation days with a reduced working percentage • Company-internal KITA on the Bachem Campus Bubendorf • 60% coverage of pension fund contributions by Bachem AG as well as the possibility for supra-mandatory provision with our choice savings plan • Access to benefit platforms with discounts at external partners • Fresh, healthy and diverse food in our staff restaurant • Diverse free sports activities on the Bachem Campus   Would you like to drive innovations forward together with us? Have we aroused your interest? Then we look forward to receiving your complete application documents via our application portal. Learn more about the Bachem Group and let yourself be inspired by our inspiring work environment at our location in Bubendorf! At Bachem, you-ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation-regardless of age, gender, background, religion, or sexual orientation. *Please note: unsolicited resumes from recruitment agencies will not be considered.* Share this job posting by email