Validation Lead

Validation Lead - Exciting Opportunity in Life Sciences

Are you a seasoned leader with a background in pharmaceuticals and a strong IT expertise? NTT DATA Business Solutions is seeking a Validation Lead to join our dynamic team. If you possess experience in GxP-regulated environments, excel in stakeholder management, and are ready to take on a diverse range of responsibilities independently, then this role is perfect for you.

The Role will involve
As a validation lead, you will be responsible for defining the validation strategy, validation planning, and reporting for our customers' implementation projects according to GAMP 5 requirements. On customer projects, you will work closely with the internal IT QA departments and staff to ensure aligned processes and validated systems delivery and you will work closely with the product owners, Line of Business (LoB), and other stakeholders to understand the scope of validation and act as liaison.

Internally in NTT Data Business Solutions, you will be responsible for keeping up to date on regulations, working closely with our Global Life Science Center of Excellence (CoE), and expanding and maintaining our Life Science assets and accelerators to enhance our ability to deliver the best services for our life science customers.

Your key tasks will include:
· Participating in large-scale IT projects as the validation expert thus responsible for the execution of validation and quality control activities

· Taking responsibility for all validation activities for the project(s) e.g., planning, documentation, coordination, and reporting, and ensuring that these are executed effectively.

· Helping to develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting a risk-based approach to testing.

· Advise customers and NDBS management on validation strategies and activities.

· QA and oversee all NDBS Nordics Life Science projects from a validation perspective ensuring that project managers and validation staff has the necessary validation deliverables and validation plans.

· Participate in our global life science community and collaborate closely with our global Life Science Center of Excellence. · Being responsible for performing various assessments such as Supplier Assessment and IT risk assessment or facilitating the workshops for these activities.

· Contributing to the validated state of internal and applications systems by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in corporation with the system managers, the QU unit and IT responsible when needed and that systems are following relevant internal and external regulatory requirements.

· Another key task will be to execute audits and inspections including finding solutions to compliance gaps identified during the procedure. You will also help the development teams to develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

· Stay on top of GxP trends and GAMP 5 regulations and document and communicate updates.

· Support the expansion of the Nordics Life Science team by contributing to the hiring of additional validation and life science capacity in our local markets.

Qualifications
To be successful in this role, you will need the following competencies:

· Strong IT competencies preferably with a master’s degree in information technology, Software Engineering or life science.

· GxP compliance experience and deep knowledge of GAMP 5, ICH Q9, and ICH Q10

· 5-10 years of extensive experience within IT Validation preferably from the pharma industry or from other regulated industries.

· Experienced in working with large-scale projects and validation.

· Familiar with working in an agile setting.

· A quality mindset with a good ability to execute within deadlines is essential.

· Strong stakeholder management, facilitation, and communication skills.

· You are a strong communicator and ambitious with an ability to follow through on the compliance ideas and initiatives in the company to the right quality level We envision that you have:

· Proven people manager skills with a sound quality culture combined with a good organizational understanding.

· Experience with medical device regulations and methodology will be an advantage.

Why you should join us:

• Experience a diverse role in a forward-thinking company, emphasizing growth in both local and global markets
• Engage with leading enterprises in the Nordic region
• Participate in transformative projects where strategic consulting meets cutting-edge technologies
• Collaborate within a network of experienced and highly skilled professionals, where your ideas and input are valued and realized
• Benefit from competitive compensation, complemented by a range of attractive employee benefits.

Additionally:
You are proactive and thrive in a challenging, dynamic, and ever-changing environment. You can handle several tasks at a time and keep an ongoing focus on results. Being open-minded and positive and having the ability and confidence to collaborate with external parties, customers, vendors, and consultants. In addition, you must have strong work ethic and willingness to take responsibility and drive success.

Discover more about us

Operating in over 30 countries with a global team of more than 14,000 colleagues, we take immense pride in our diverse and inclusive work environment. In the Nordic region, we have approximately 550 colleagues based in Denmark, Norway, Sweden, and Finland.

As an employer, our people are valued and percieved as our most important asset. Our culture is built on a trust-based work environment, valuing individual autonomy, promoting open dialogue, and fostering a strong professional community.

Contact
If you find this position interesting, please send us a few words about yourself as well as your CV and we will get back to you shortly. We are conducting interviews on a daily basis, so please do not hesitate with sending you CV.

Do you have questions?
If you have questions regarding the position or NTT DATA Business Solutions as a workplace, feel free to contact me.

Malak Bakir
E-Mail: [email protected]

We transform. SAP® solutions into Value
NTT DATA Business Solutions is a fast-growing international IT company and one of the world’s leading SAP partners. We are a full service provider delivering everything from business consulting to implementation of SAP solutions, including hosting services and support. NTT DATA Business Solutions employ more than 10.000 highly qualified people in 26 countries divided in 5 regions. In the Nordic region, NTT DATA Business Solutions employ approx. 500 people in Denmark, Norway, Sweden and Finland.

Valby, DK, 2500

Aarhus, DK, 8000

Horsens, DK, DK-8700

Aalborg, DK, 9000

Apr 25, 2024