Senior Manager, Computer System Validation/Compliance Delivery Lead - Life-Sciences and Healthc ...

Deloitte's Life-Sciences and Healthcare (LSHC) team works on the forefront of digital innovation and technology change within the industry. Our clients engage us to collaborate on many interesting and complex problems ranging from transforming legacy technology, through to building brand new digital banks and propositions.

As part of the LSHC industry practice, you'll be working with a multitude of market leading teams from Deloitte to deliver value to our clients across the value chain (with a focus on quality, regulatory compliance, and delivery excellence). Starting from strategy and proposition definition to detailed operations and tech design and being part of engineering and implementation teams to deliver for our clients. We have a diverse team with vast knowledge, experience and backgrounds enabling us to provide the best value to our clients. Within our team you will have the opportunity to work alongside and collaborate with industry experts as well as having access to a range of both internal and industry certified learning courses and qualifications.

If you want to be part of our growing team, work with our clients to reshape the LSHC and help to develop junior talent, we would be delighted to hear from you.

Connect to your career at Deloitte Deloitte drives progress. Using our vast range of expertise, we help our clients' become leaders wherever they choose to compete. To do this, we invest in outstanding people. We build teams of future thinkers, with diverse talents and backgrounds, and empower them all to reach for and achieve more.

What brings us all together at Deloitte?It's how we approach the thousands of decisions we make everyday. How we behave, our beliefs and our attitudes. In other words: our values. Whatever we do, wherever we are in the world, we lead the way, serve with integrity, take care of each other, foster inclusion, and collaborate for measurable impact. These five shared values lead every decision we make and action we take, guiding us to deliver impact how and where it matters most.

Connect to your opportunity Are you a driven professional who wants to make an impact within the Life-Sciences and Healthcare Industry?

Are you passionate about leading strategic initiatives or complex transformation programs from a regulatory compliance, quality and delivery excellence perspective?

Do you thrive on contributing to the growth of a practice that delivers impactful & compliant solutions for clients?

Do you have an entrepreneurial mindset that drives continuous innovation, a big-picture perspective, and the ability to establish innovative services and solutions that help clients transform, advise on their strategic & regulatory challenges, and ensure compliance?

As a Manager/Senior Manager in our Life-Sciences & Healthcare team, you will have the opportunity to:

• Lead CSV and Regulatory Compliance Team and engagements:
  • Manage and execute end-to-end computer system validation projects, ensuring compliance with GxP regulations (e.g., GMP, GCP, GLP, GVP), 21 CFR Part 11, Annex 11, and other relevant industry standards (e.g., GAMP 5).
  • Develop and implement risk-based validation strategies, plans, and documentation (e.g., Validation Master Plans, User Requirements Specifications, Functional Specifications, Design Specifications, Test Plans, Traceability Matrices, Validation Reports).
  • Provide expert guidance on data integrity, electronic records, and electronic signatures.
  • Advise on Quality Management System (QMS) design, implementation, and optimisation within a regulated life sciences environment.
• Drive Project Management & Delivery Excellence:
  • Lead project workstreams or clients' strategic initiatives, taking ownership of project planning, resource allocation, budget management, and timely delivery of high-quality deliverables.
  • Manage client relationships effectively, acting as a trusted advisor and ensuring client satisfaction.
  • Apply robust project management methodologies (including agile principles where appropriate) to ensure efficient and effective project execution.
  • Identify and mitigate project risks, proactively addressing challenges to keep projects on track.
• Contribute to Service Offering Growth:
  • Support business development activities, including contributing to proposals, developing thought leadership, and identifying new client opportunities.
  • Mentor and coach junior team members, fostering their professional development in CSV, regulatory compliance, and project management.
  • Stay abreast of evolving regulatory landscapes and industry best practices in life sciences and technology.

Connect to your skills and professional experience

• A bachelor's degree or equivalent in a relevant scientific, engineering, or technology discipline (e.g., Pharmacy, Biotechnology, Computer Science, Biomedical Engineering)
• Proven experience in Computer System Validation (CSV) and/or regulatory compliance within the Life Sciences & Healthcare industry (Pharmaceutical, Biotech, Medical Devices).
• Demonstrable expertise in GxP regulations (e.g., GMP, GCP, GLP, GVP), 21 CFR Part 11, Annex 11, and GAMP 5.
• Good understanding of the different standards applicable within the LSHC domain e.g. ISO-13485, ISO-14971
• Proven experience in leading and managing projects or significant workstreams, demonstrating strong project management skills (e.g., planning, execution, risk management, stakeholder communication).
• Familiarity with agile methodologies and their application in regulated environments.
• Excellent analytical, problem-solving, and critical thinking abilities.
• Strong communication, negotiation, presentation, and interpersonal skills, with the ability to articulate complex concepts clearly to diverse audiences.

Preferably you will also have:

• Relevant professional certifications (e.g., PMP, PRINCE2, CSQA, CISA).
• Master's degree or equivalent advanced qualification.
• Experience with Quality Management Systems (QMS) implementation or optimisation.
• Familiarity with agile methodologies and their application in regulated environments.
• Experience with various enterprise systems (e.g., ERP, LIMS, QMS, EDMS, Clinical Trial Management Systems) used in life sciences

Connect to your business - Technology and Transformation Distinctive thinking, deep expertise, innovation and collaborative working. That's what connects us. That's what makes us Deloitte. If you want to help solve some of the biggest tech and transformational challenges around, join us. Together, we'll make an impact that matters.

Engineering, AI and Data We lead transformation at the heart of our clients; re engineering the core of our clients' organisations, helping to unleash growth, and creating better futures for their customers, citizens and employees.

Personal independence Regulation and controls are standard practice in our industry and Deloitte is no exception. These controls provide important legal protection for both you and the firm. We are subject to a number of audit regulations, one of which requires that certain colleagues abide by specific personal independence constraints (e.g., in relation to any financial interests and employment relationships). This can mean that you and your "Immediate Family Members" are not permitted to hold certain financial interests (shares, funds, bonds etc.) with audit clients of the firm, and also prohibitions on certain employment relationships (e.g., you are not permitted to hold a secondary employment role with SEC audit clients of the firm whilst being employed by the firm). The recruitment team will provide further detail as you progress through the recruitment process or you can contact the Independence team upon request.

Connect with your colleagues "I get to work on projects that help clients in a sector I feel truly passionate about." - Rhiannon, Engineering, AI & Data

"Everyone always says, 'it's the people,' and that's true. Working for a brand you feel proud of feels pretty good too. And you don't have any stress about fitting into a particular stereotype, because there are so many different types of people in Deloitte Digital." - Gillian, Engineering, AI & Data

Our hybrid working policy You'll be based in London with hybrid working.

At Deloitte we understand the importance of balancing your career alongside your home life. That's why we'll support you to work flexibly through our hybrid working policy. Depending on the requirements of your role, you'll have the opportunity to work in your local office, virtual collaboration spaces, client sites and remotely. You'll get the chance to meet face to face when needed, while you collaborate and learn from colleagues, share your experiences, and build the relationships that will fuel your career and prioritise your wellbeing. Please check with your recruiter for the specific working requirements that may apply for your role.

Our commitment to you Making an impact is more than just what we do: it's why we're here. So we work hard to create an environment where you can experience a purpose you believe in, the freedom to be you, and the capacity to go further than ever before.

We want you. The true you. Your own strengths, perspective and personality. So we're nurturing a culture where everyone belongs, feels supported and heard, and is empowered to make a valuable, personal contribution. You can be sure we'll take your wellbeing seriously, too . click apply for full job details