Senior Validation Manager

4 tygodni temu

Warszawa, Mazovia, Polska Fusion Cons Pełny etat

Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.

With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions.

Focused on S4HANA, data & cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake.

Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality.

Job Description

Key Responsibilities

We are looking for an experienced and driven validation manager to lead and manage validation activities across various project settings ranging from SAP implementation, upgrade or enhancement to transformational projects. This role will cover 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 complying 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.

The ideal candidate will bring a deep understanding of validation processes, strong leadership skills and the ability to navigate complex project environments. Your role will be pivotal in driving successful project outcomes whilst maintaining regulatory compliance and ensuring lasting validation excellence.

  • Develop, refine and implement robust validation strategies that ensure compliance whilst maintaining seamless operations.
  • Lead and oversee all operational validation or quality related activities within the client's organization.

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.
  • 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.
  • 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.
  • Strongly seek improvement for test management, document management and change control management activities.
  • 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 (BSc, MBA, MSc) innatural sciences,information technology,engineering, pharmacy or any related field.
  • A proven track record with 5+ years of experience in a validation manager or quality assurance role within the pharmaceuticalorlife sciencesindustry.
  • Strong knowledge and application of regulatory guidelines and standards for highly regulated environments(pharmaceuticals or life sciences), including in-depth understanding of GxP validation methodologies, quality management standards (e.g. ISO-27001, ISO-9001) and GAMP 5 & regulatory compliance (FDA, EMA, etc.).
  • Expertise in both agile and waterfall validation strategies, e.g. including lean validation methods.
  • Experience with business mapping and process modelling.
  • Proficient in project management practices, with the ability to manage complex, cross-functional projects.
  • Exceptional problem-solving skills with attention to detail and the ability to resolve complex issues effectively.
  • Proficiency in relevant software tools and systems used in validation processes.
  • Demonstrated experience in identifying, assessing and mitigating risks.
  • Excellent communication skills, including the ability to engage and collaborate with both technical and business stakeholders. Strong presentation skills, capable of e.g. organizing and leading workshops.
  • A dedicated team player, skilled at working cross-functionally and collaborating with international teams to drive project success.
  • Fluent in English (written and spoken) is a must. Fluent in German (written and spoken) is a significant advantage.
Additional Information

Why Fusion?

At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.

We value employees who challenge the status quo through innovation, adapt to diverse client needs in ever-changing environments, and commit to continuous learning—for themselves and their colleagues.

We provide a competitive salary and benefits package, along with an outstanding work environment that fosters long-term career development opportunities.

  • Workflex: Enjoy 25 days of flexibility to work from your preferred global location.
  • Flexible Time Off: Take the time you need to recharge and maintain a healthy work-life balance, with flexibility beyond standard holiday allowances.
  • Annual Training Budget: Access CHF 1,500 to invest in your professional development and skill enhancement.
  • Continuous Learning: Thrive in an environment that encourages ongoing learning, with opportunities to develop new skills and broaden your expertise.
  • Global Mobility Support: Gain assistance with international assignments, visa/permit support, and relocation services.
  • Unity Scheme: Benefit from loyalty rewards starting after 3 years of service.
  • Referral Program: Earn a referral fee for every successfully hired referee.
  • Local Benefits: Access a range of country-specific benefits tailored to your location.
  • People Focus: Unite with the best global talent in life sciences, empowered to grow and collaborate in a vibrant environment.
  • Truly Global: Join a truly global organization where mutual support, teamwork, and diversity drive our collective success.
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