Senior Manager, Computer System Validation/Compliance Delivery Lead - Life-Sciences and Healthc[...] in City of London

Senior Manager, Computer System Validation/Compliance Delivery Lead - Life-Sciences and Healthc[...] in City of London

City of London Full-Time 36000 - 60000 £ / year (est.) Home office (partial)
Deloitte LLP

At a Glance

  • Tasks: Lead innovative projects in Life-Sciences and Healthcare, ensuring compliance and quality.
  • Company: Join Deloitte, a leader in digital innovation and technology change.
  • Benefits: Flexible hybrid working, professional development, and a supportive culture.
  • Other info: Dynamic team environment with opportunities for mentorship and continuous learning.
  • Why this job: Make a real impact in healthcare while growing your career with industry experts.
  • Qualifications: Experience in Computer System Validation and regulatory compliance is essential.

The predicted salary is between 36000 - 60000 £ per year.

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. Because it’s only when you’re comfortable and at your best that you can make the kind of impact you, and we, live for.

Your expertise is our capability, so we’ll make sure it never stops growing. Whether it’s from the complex work you do, or the people you collaborate with, you’ll learn every day. Through world‑class development, you’ll gain invaluable technical and personal skills. Whatever your level, you’ll learn how to lead.

Connect to your next step

A career at Deloitte is an opportunity to develop in any direction you choose. Join us and you’ll experience a purpose you can believe in and an impact you can see. You’ll be free to bring your true self to work every day. And you’ll never stop growing, whatever your level.

Discover more reasons to connect with us, our people and purpose-driven culture at deloitte.co.uk/careers

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Senior Manager, Computer System Validation/Compliance Delivery Lead - Life-Sciences and Healthc[...] in City of London employer: Deloitte LLP

Deloitte is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the Life-Sciences and Healthcare sector. With access to extensive professional development opportunities and a commitment to employee wellbeing, you will thrive in a supportive environment that values diversity and encourages personal growth. Located in London, our hybrid working policy allows for flexibility, ensuring you can balance your career aspirations with your personal life while making a meaningful impact on clients and the industry.

Deloitte LLP

Contact Details:

Deloitte LLP Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Senior Manager, Computer System Validation/Compliance Delivery Lead - Life-Sciences and Healthc[...] in City of London

Join Compliance Communities

Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!

Attend Industry Conferences

Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.

Leverage Your University Career Services

If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.

Showcase Your Knowledge Online

Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Deloitte LLP looking for candidates who are engaged and informed.

We think you need these skills to ace Senior Manager, Computer System Validation/Compliance Delivery Lead - Life-Sciences and Healthc[...] in City of London

Computer System Validation (CSV)
Regulatory Compliance
GxP Regulations (GMP, GCP, GLP, GVP)
21 CFR Part 11
Annex 11
GAMP 5
Risk-Based Validation Strategies

Some tips for your application 🫡

Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!

Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.

Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!

Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Deloitte LLP. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!

How to prepare for a job interview at Deloitte LLP

Master the Regulations

Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!

Show Your Analytical Skills

Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!

Know Your Tools

Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!

Align with Company Culture

Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Deloitte LLP’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!