Full-Time Senior Validation Manager

Key ResponsibilitiesWe are looking for an experienced and driven validation manager to lead and manage validation activities across various project settings. This role covers qualification activities, computer system validation, process validation and ensuring compliance with regulatory standards.

As the validation manager, you will be responsible for ensuring that all project deliverables meet the highest quality standards and comply to regulatory guidelines throughout the project lifecycle.

You will work closely with cross-functional teams, including stakeholders from business, quality assurance, and IT experts to align validation strategies with project objectives and timelines.

Validation Strategy & Implementation:Develop, refine and implement robust validation strategies that ensure compliance whilst maintaining seamless operations.Lead and oversee all operational validation or quality related activities.

Documentation & Compliance:Ensure all validation documentation – system lifecycle documents, change controls, reports and other protocols – are comprehensive, accurate and fully compliant with regulatory standards / company policies following good documentation practice.Provide support for testing activities to guarantee adherence to quality standards and regulatory requirements.

Risk Management:Conduct risk assessments to identify validation-related risks and formulate effective mitigation plans.Apply a risk-based approach to prioritize validation of critical systems and processes.Serve as the subject matter expert for validation during regulatory audits and inspections, offering expert guidance and assurance.

Continuous Improvement:Regularly assess and optimize validation processes to identify opportunities for improvement and integrate industry best practices.Act as the first point of contact for managing critical incidents, deviations and CAPA (corrective and preventive action) processes.Ensure rigorous management of compliance aspects throughout the project lifecycle, whilst maintaining close communication with key stakeholders.Provide ongoing compliance guidance and deliver training to team members to ensure consistent regulatory adherence.

Training & Mentorship:Lead and mentor your team on validation methodologies, principles and best practices.Cultivate a culture of continuous improvement and ensure that compliance is embedded and plays a pivotal role within the validation team’s daily operations as well as in the wider project context.

Qualifications:Bachelor’s or master’s degree in related fields.A proven track record with 5+ years of experience in a validation manager or quality assurance role within the pharmaceutical or life sciences industry.Strong knowledge and application of regulatory guidelines and standards for highly regulated environments.

Skills:Expertise in GxP validation methodologies, quality management standards, GAMP 5, regulatory compliance (FDA, EMA, etc.).

Other Skills:Expertise in both agile and waterfall validation strategies, lean validation methods.Experience with business mapping and process modelling.Proficient in project management practices.Exceptional problem-solving skills with attention to detail.Proficiency in relevant software tools and systems used in validation processes.Demonstrated experience in identifying, assessing and mitigating risks.Excellent communication skills, presentation skills.

Language skills:Fluent in English (written and spoken). Fluent in German is a significant advantage.

What is the last date for applying to the job?

Which countries are accepted for this remote job?