Document Control Manager

Document Control Manager - Biopharma - 12 months - Berlin

A global Biopharmaceutical company requires an experienced Document Control Manager who has previously worked to deliver complex projects. The role of the Document Control Manager will be to manage and coordinate the documentation activities for a large capital investment programme based in Germany.

Reporting into the Project Director, this individual will be responsible for the delivery of the documentation for a highly complex Greenfield Biologics Facility Build.

German language is essential.

Responsibilities:

1. The Document Control Manager will be responsible for setting up and maintaining the Project Document Control Department throughout the full lifecycle of a complex Biotech build.
2. Responsible for growing the Document Control team.
3. Responsible for the creation and execution of complex protocols and procedures for the project document control system.
4. Coordinates and chairs Document Control meetings.
5. Supports user requests for documentation and trains users in Document Management.
6. Administers the training system in Document Management, setting up users as required.
7. Investigates and responds to corrective actions related to Document Control and Training.
8. Responsible for coordinating document change requests, facilitating review, approval, and retention of Risk Management documents.
9. Executes document control protocols and procedures in functional work areas, processing incoming and outgoing documents including receipt, classification, registry, distribution, archiving, storage, and retrieval.
10. Develops knowledge and understands project management principles, quality systems, quality plan, and working procedures.
11. Implements elements of project management and quality within the scope of the project document control department.
12. Continuously identifies opportunities for enhancements in the document control process.

Experience:

1. Significant experience in a Senior Document Control function on Large Scale Projects within the Biologics or Pharmaceutical industry. This person should have experience with design and construction projects for biopharmaceutical manufacturing facilities.
2. Minimum 10 years’ experience in controlling qualification and validation documents.
3. Work with all departments and with all levels of the organisation, and with contract vendors engaged in design and construction.
4. Ability to keep work pace and meet deadlines. Good organising and planning skills.
5. Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers, and operations staff.
6. Proven success working well in a team environment with flexibility to react to changing business needs.
7. Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.

If this role is of interest to you, please apply now!