QA Documentation Manager

Inceptua is a global pharmaceutical services company with market-leading capabilities across multiple business areas. We have over 25 years of experience serving life science companies of various sizes and global operations with offices across Europe, North America, and Asia.
We provide clinical trial supply, services and logistics, including comparator sourcing of medicines, packaging, labelling, storage, and distribution services. And we offer strategic advice, design, facilitation, and implementation of global early access programs, and distribution of unlicensed and other medicines worldwide.
Our success is based on the motivation, dedication and performance of our people. We strive to go the extra mile and achieve excellence in all our services. Read more about us

We are recruiting for a QA Documentation Manager to be based in Berlin (Germany) on a one-year contract, with an immediate start date.

You will become part of our global Quality Assurance (QA) Team and you will be responsible for managing and overseeing the creation, review, approval, storage, and maintenance of all quality-related documents. This role ensures that all documentation is in compliance with good documentation practices and our quality management system. You will be working closely with different internal functions.

Responsibilities include, but are not limited to:

Document Control Management

• Manage Inceptua`s electronic Quality Management System (eQMS, ZenQMS) used for tracking, updating, and storing documents.
• Oversee the entire lifecycle of controlled documents, including Standard Operating Procedures (SOPs), policies, procedures, working instructions, and all other GxP-related documentation.
• Ensure that all documentation is accurate, properly reviewed, approved, and archived in accordance with good documentation practices requirements.

Compliance, continuous improvement & audits

• Ensure applicable GxP compliance and that the Quality Management System is maintained and improved.
• Ensure documentation readiness for regulatory inspections and audits by or ganizing, preparing, and maintaining compliance records.

Reviews & Approvals

• Ensure timely completion of document revisions and approvals in alignment with project timelines and regulatory submission deadlines.
• Coordinate with departments for the periodic review of critical documentation, ensuring updates are made as needed.

Your profile:

• You hold a University degree in Life Sciences (e.g., Biology, Biochemistry, Pharmacy) or Quality Management
• You have a minimum of 3-5 years’ experience in a documentation management role withing the pharmaceutical or life science industry
• You have a prove experience with with electronic Quality Management Systems, experience with ZenQMS would be an advantage
• You are business fluent in English
• You have a pragmatic Quality mind-set and are a proactive team player with a solution-oriented mindset
• You are able to work in an international and multi-cultural setting with tight deadlines
• You are able to communicate effectively, and with sensitivity to a wide range of people including externally to both vendors and clients

This position is full-time with a hybrid schedule (three fixed days per week in the office, and the flexibility to work from home the two other days).

Our company is home to employees from various backgrounds that speak a range of languages. With teams across different locations and cultures, we value diversity and believe inclusive collaboration makes us stronger.