Senior Validation Manager
Senior Validation Manager
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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 crossfunctional 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.
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 within the clients 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.
Risk Management:
- Conduct risk assessments to identify validationrelated risks and formulate effective mitigation plans.
- Apply a riskbased 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.
- Strongly seek improvement for test management document management and change control management activities.
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 teams daily operations as well as in the wider project context.
Qualifications :
- Bachelors or masters degree (BSc MBA MSc) in natural 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 pharmaceutical or life sciences industry.
- Strong knowledge and application of regulatory guidelines and standards for highly regulated environments (pharmaceuticals or life sciences) including indepth understanding of GxP validation methodologies quality management standards (e.g. ISO27001 ISO9001 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 crossfunctional projects.
- Exceptional problemsolving 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 crossfunctionally 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 gamechanging solutions that build lasting relationships with our clients.
We value employees who challenge the status quo through innovation adapt to diverse client needs in everchanging environments and commit to continuous learningfor themselves and their colleagues.
We provide a competitive salary and benefits package along with an outstanding work environment that fosters longterm career development opportunities.
Our Benefits:
- 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 worklife balance with flexibility beyond standard holiday allowances.
- Annual Training Budget: Access CHF 1500 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 countryspecific 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.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
