Life Sciences Re­gu­la­tory Com­pli­an­ce and Va­li­da­tion Lead

 

Do you want to make a real impact?

Capgemini Denmark’s Life Science sector is seeking a Regulatory Compliance Lead for developing and leading regulatory compliance and validation programs across our major accounts as well as develop our competencies in this strategic area.

As our Compliance and Validation Lead, you will be part of a dynamic and fast-growing team. While your focus will be on the Danish market and clients, you will act on a global playing field. Here, you will have a great exchange of knowledge and collaboration and bring the right assets to our Danish clients and prospects, while supporting the focused efforts on asset development globally to further strengthen our market position.

You Role

As our Regulatory Compliance Lead, you will:

  • Lead compliance work streams across strategic programs and projects as responsible for end-to-end quality and compliance activities.
  • Work collaboratively across functions with Quality, IT, Business, and Vendors to plan, coordinate and execute computer system validation activities.
  • Perform risk-based validation of GxP systems, develop validation documents in accordance with the CSV processes, to ensure requirements coverage
  • Be responsible for the development and delivery of a complete validation packages, incl. User Requirements Specification (URS), Validation Plan (VP), Installation/Operational/Performance Qualification Protocol (xQP), Traceability Matrix (TM), Administration and User SOPs, etc.
  • Facilitate verification and validation activities including User Acceptance Testing (UAT), test execution, documentation review, and approval.
  • Build up and grow competencies local and globally.
  • Act as team lead and mentor for junior consultants in Denmark (and nearshore/offshore) as needed.
  • Provide thought leadership with respect to compliance and validation activities within our internal and external communities.
  • Review and sign off on approach, solutioning and estimation, compliance and validation tasks in relation to strategic bids and proposal responses.
  • Lead and participate in shaping key service offerings at a local and global level.

We see the following experiences and skills as meriting:

  • Ability to build trusted advisor relationship with clients’ compliance officer, QAs and and key business and IT stakeholders
  • Strong Pharma/ R&D/ Life Sciences compliance background and experience with working with validated computer systems
  • Minimum 6+ years of pharmaceutical Quality Management and GxP system validation experience
  • Experience working with the guidelines provided by the global regulatory agencies and authorities agencies such as FDA and MHRA in areas including but not limited to GxP, 21 CFR Part 11, ERES, CAPA, GAMP, CSV, etc.
  • Good knowledge about GAMP framework
  • Solid project management skills
  • Excellent communication skills and fluent English (both spoken and written)
  • Self-started and self-motivated, eager to adhere to Capgemini’s values of Honesty, Boldness, Trust, Freedom, Team Spirit, Modesty and Fun.
  • You have business drive and acumen.
  • You are a team player and demonstrate strong interpersonal and business management skills.
  • You value business growth and people development.

What we’ll offer you

Professional development. Accelerated career progression. A global Life Sciences Community. An environment that encourages entrepreneurial spirit. Global opportunities. It’s all on offer at Capgemini. And although collaboration is at the heart of the way we work, we also recognize individual needs with a flexible benefits package you can tailor to suit you.

Why we’re different

At Capgemini, we help organizations across the world become more agile, more competitive and more successful. Smart, tailored, often-groundbreaking technical solutions to complex problems are the norm. But so, too, is a culture that’s as collaborative as it is forward thinking. Working closely with each other, and with our clients, we get under the skin of businesses and to the heart of their goals. You will too.

Capgemini positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity. We are committed to hiring, developing, and retaining the best people to deliver innovative, world-class solutions for our clients. We foster an inclusive culture that enables everyone to achieve their full potential and enjoy a fulfilling career with us. Our comprehensive flexible benefits package and lifestyle policies enable our employees to balance their individual, family and work-life needs.

Interested?

If you have any questions about this position, you are welcome to contact Life Sciences Sector Lead John Fodeh at john.fodeh@capgemini.com.

We look forward to hearing from you.

Application Deadline: Oct. 31, 2021

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