Your new company
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs over 6,000 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
Ferring TechOps IT Infrastructure is a newly established team (March 2022) with the overall responsibility to define, pilot, implement, and eventually operate a new greenfield industry best-practice TechOps IT infrastructure. The TechOps Infrastructure team is part of the Corporate Infrastructure & Security organization in Global IT, with team members primarily working out of the Global IT headquarter in Copenhagen, Denmark and out of Lisbon, Portugal. The team consists of highly skilled and experienced individuals who thrives in a team setting and wants to succeed around the same mission.
Your new role
In your role as an IT Compliance Lead, you will take up the key role and responsibilities to:
- Plan, coordinate and execute computer system validation activities in cross-functional collaboration with Quality Assurance, IT, Line of Business and vendors.
- Perform risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes.
- Be responsible for the development and delivery of complete validation packages according to the Ferring procedures.
- Facilitate verification and validation activities including test execution, documentation review and approval.
- Provide guidance to project and operational teams in relation to policies, standard, practices and regulations that require adherence.
- Responsible for future internal audit investigations of the infrastructure services ensuring the organization maintains compliance and feeding irregularities and areas for improvement in the Continuous Service Improvement process.
- Maintain knowledge and coordinate the response to all internal and external audits, ensuring that the relevant team is aware and responds promptly and efficiently, applying the necessary improvements.
- Responsible for planning, implementing, and executing all required quarterly, semi-annual, and annual IT user access review processes.
- Coordinate, facilitate, track, and monitor status of all user access reviews (application, operating system, database layers, etc.)
What you'll need to succeed
- University degree or equivalent in information systems.
- 5+ years relevant work experience as an IT Compliance Lead within the infrastructure and security domain, preferably within the pharmaceutical industry.
- Experience working with the guidelines provided by the global regulatory agencies and authority agencies such as FDA and MHRA, e.g., GxP, USP1058, FDA 21CFR part 11, GAMP Annex11, MHRA ‘GXP’ Data Integrity Guidance and Definitions, PIC/S or corporate interpretations hereof.
- ITIL Foundation qualification or equivalent experience.
- ISO Internal Auditor or equivalent experience.
- GDPR Practitioner or equivalent experience.
- Good knowledge about GAMP framework.
- Experience of developing policy and process management standards.
- Experience of producing high quality policy and process documentation.
- Experience in working with external IT-service providers.
- Experience with ITSM tools (ServiceNow is a plus).
- Experience working within regulated industries.
- Excellent organizational, coordination, interpersonal and communication skills and experience working in an international team across locations and time-zones.
- Fluency in English.
What you'll get in return
Do you want to be part of the team to shape and accelerate the transformation of Ferring’s TechOps IT infrastructure? Do you have a proven track record across IT Infrastructure, Security and/or Manufacturing? If yes, then you are the person we are looking for to join our newly established TechOps Infrastructure team. Our mission is to be part of rebuilding Ferring’s TechOps IT infrastructure for the future.
What you need to do
If you are interested in this opportunity, click on “Apply Now” to forward us your updated CV. In case this is not the opportunity you are looking for, contact us to talk about other career opportunities, always in a confidential mode.
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