Senior Consultant Compliance & Data Integrity (m/f)

Ideas need initiative.


Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Werum’s PAS-X software product is run by more than half of the world’s top 30 pharmaceutical and biotech companies as well as many mid-sized drug manufacturers. Founded in 1969, Werum is headquartered in Lüneburg, Germany, and has locations in Europe, America, and Asia. Werum is part of the Körber Group’s Business Area Pharma Systems.


The Business Area Pharma Systems provides high quality solutions for the production, inspection and packaging of pharmaceutical products and unites seven internationally successful companies under one roof.


The Körber Group is an international technology group with around 11,000 employees all over the world. It unites technologically leading companies with 140 production, service, and sales companies and offers its customers solutions, products, and services in the Business Areas of Automation, Logistics Systems, Pharma Systems, Tissue, Tobacco, Corporate Ventures and Körber Digital.

For our location in Lüneburg we are looking for

Senior Consultant Compliance & Data Integrity (m/f)

Tasks:

  • Responsible to surveillance and ascertain compliance of Werum products to applicable regulatory requirements:
    • Definition, assessment and verification of functional requirements
    • Creation of Process Data Flow Maps based on Business Process Descriptions
    • Providing guidance for software development in our products and projects
    • First contact for all compliance and DI related questions (internal and external)
    • Compliance Trainings of Werum Employees
  • Participation in vendor audits and data integrity audits
  • Representation of compliance and data integrity in Werums user community and international committees
  • Creation of Data Integrity White Papers
  • Development and provision of consulting services regarding compliance and data integrity
  • With respect to compliance and data integrity
    • Consult & Train client associates of Werum’s software
    • Understand functionality provided by Werum’s software for the purpose of consulting customers
    • Support projects in all areas of the PAS-X software development lifecycle
    • Provide management support
  • Assume responsibility to complete projects or activities
  • Work independently and guide Junior Consultants & Consultants
  • Mentor new staff members and motivate them with regard to assigned objectives

Qualifications:

Desired Skills:

  • Excellent knowledge of applicable pharmaceutical regulations and industry guideline including but not limited to:
    • US FDA 21 CFR Part 211, 11 and cGMP publications
    • EU GMP Guideline and Annex 11
    • ICH Q8, Q9, Q10, Q12
    • Industry Guidelines such as ISPE GAMP5 and appropriate Industry Good Practice Guidelines
    • Relevant regulatory Data Integrity guidelines from MHRA, WHO, FDA, PIC/S
    • Relevant Data Integrity industry best practice guidelines
  • Ability to explain and ‘translate’ regulatory verbalizations: Assess, transfer and map day-to-day software/technical questions to the relevant and applicable regulation
  • Sound understanding of pharmaceutical processes and expectations of regulated companies
  • Self-motivated, energetic and enthusiastic personality
  • Independent way of working
  • Strong analytical skills and excellent verbal and written communication skills in German and English
  • Thorough understanding of the software project life cycle
  • Severe understanding of the Pharmaceutical environment and regulatory authorities
  • Ability to work in different roles and collaborate in virtual teams
  • Ability to collaborate in teams
  • Willingness to travel, approx. 50-70%

 

Desired Experience:

  • 5 years of compliance, computer system validation and data integrity experience in a consulting / training role
  • Experience with FDA regulated environments (drug production & validation)
  • A project management certification (PMP, IPMA) is a plus
  • Experience with Werum’s MES solution PAS-X is a big plus
  • A Bachelor of Science Degree in a Science or Computer Science field is required, a Master of Science Degree is preferred