Validation Manager

Stellenbeschreibung:

Your mission

As a Validation Manager (m/f/d), you will play a key role in advancing our innovative drug development program. You will take ownership of all validation activities in the development of our products. Working closely with multidisciplinary teams and external partners, you will ensure our processes and products meet the highest standards of quality, safety, and regulatory compliance.
Key responsibilities:
Reporting to the Senior Director of Quality, the Validation Manager will have responsibility to develop and manage all validation activities under the Quality Management System:

Provide expert advice on the validation strategy for development programs.

Develop and maintain the Validation Master Plan (VMP).

Develop systems, processes, tools and templates for the conduct of qualification and validation activities.

Work cross functionally to develop qualification and validation protocols in accordance with the requirements of the VMP.

Review and approve qualification and validation reports.

Project Management of validation activities.

Initiate and manage deviations, changes and risk assessments in the conduct of validation activities.

Quality oversight of the stability program.

Quality oversight and support for technical transfer activities.

Support the ongoing continuous improvement of the company's QMS in compliance with applicable GxP requirements and regulatory guidelines.

Leading Quality Excellence:

Lead by example in promoting and facilitating a quality culture.
Work cross functionally to provide quality oversight, support and expertise in the conduct of quality related activities across development projects, employing Quality by Design (QbD) principles.
Provide training to staff on quality topics.
Support the conduct of quality investigations and initiatives.
Prepare, manage and present materials for Quality Management Review.

Your profile

At least 5 years of hands-on experience of validation in a GMP sterile manufacturing environment, ideally in a development setting.
Strong understanding of and experience of GMP requirements in the EU and US and sound knowledge of applicable ICH guidelines.
Demonstrated expertise in the management of validation activities.
Experience of method validation, process validation and equipment qualification.
Experience of Computer System validation is an advantage.
Excellent problem-solving, analytical, and communication skills.
Familiarity with electronic Quality Management Systems (eQMS).
Fluent in English.

Why us?

Competitive compensation, based on base salary and stock options
Hybrid working model
Key role in a highly advanced and fast-growing startup company
Ample opportunity for personal initiatives, openness to new ideas and room for considerable personal impact
Impactful product promoting better understanding and treatment of disease
International team, from over 20 different nationalities
Enjoyable work atmosphere with an open-door and open communications mentality
Indefinite employment contract, providing stability
Long-term career growth opportunities
30 vacation days
Relocation support