Site Data Integrity Lead

Site Data Integrity Lead
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role

In this position you will be responsible for Data Integrity strategy improvements and implementations. Cross-functional relationships building and ability to conjoin understanding of potential risks with skillful mitigation of such via effective regulation and procedures within GMP regulated environment will be crucial.

Your responsibilities
  • Manage and support the data integrity improvement strategy for the site and serve as point of contact for the site for the data integrity improvement strategy
  • Provide structure, guidance, alignment, and monitoring of Data Integrity improvement strategy across all functions
  • Perform risk assessments to determine high risk/priority equipment and audit trails and take appropriate action to bring into compliance
  • Assist in sourcing, assessing, and recommending instrumentation/equipment for purpose that mitigates identified risks
  • Establishes and Chairs the site Data Integrity Governance Team Meetings
  • Deliver compliant regulatory data integrity strategy and processes
  • Develop and implement site specific Data Integrity improvement plan including all relevant analytical laboratories and manufacturing operations on the site
  • Build partnerships with key site functions (e.g., Production, Technical, Planning, Engineering and Quality) to ensure alignment with data integrity requirements based on regulatory standards
  • Support the business in process development, benefits management, planning, and change management with regard to Data Integrity
  • Ensure that strategies and programs are well defined such that they can successfully deliver the required outcomes, with understood and managed risks, deliverables, benefits, costs, resources and quality
  • Provide subject matter expertise to regulatory inspections and interact with auditors as necessary
  • Creates/updates procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations
  • Routinely evaluates regulatory inspection documents and updates site procedures accordingly
  • Keeps the governance team aware of industry trends all within the scope of Data Integrity
  • Trains and motivates staff of all levels on the Data Integrity fundamentals
  • Provides time delivery of KPIs for Data Integrity
  • Escalate critical incidents according to the escalation process
If you have
  • Master Degree in the field of Science
  • 3+ years experience as a Data Integrity Lead in a pharmaceutical or other highly regulated GMP manufacturing environment
  • Experience performing risk assessments to determine high risk/priority equipment and audit trails and taking appropriate action to bring into compliance
  • Project management skills
  • Experience interfacing cross functionally with operational and senior level management within the organization
  • Technical expertise in Quality Assurance, Validation, Equipment and/or Laboratory Automation
  • Strong analytical skills to identify business requirements and to provide solutions to complex issues
  • Experience in most or all of the systems lifecycle (i.e., strategy, prioritization, design, development, implementation and operations) stages
  • Possesses strong leadership qualities and ability to motivate teams of highly skilled and trained individuals
  • Experience in effective interaction (both verbal and written) with all levels of the organization
  • Good written and verbal skills, fluent English.
Join our Team!
Why you should work with us
Contact us

    ISS Facility Services Sp. z o.o.

    mazowieckie / Warszawa


    Help Desk Agent ze znajomością j. chińskiego

    Job description: Receiving reports from employees about failures and technical faults in the office Registration of notifications and monitoring their status Providing employees with information on the status of notifications and implementation stages...

    LUX MED Sp. z o.o.

    mazowieckie / Warszawa, ul. Iłżecka 24f


    Koordynator / Koordynatorka Działu Raportów i Analiz w Contact Center

    Praca w wewnętrznym Contact Center Grupy LUX MED przy ulicy Iłżeckiej 24f w Warszawie. Nasze oczekiwania: wykształcenie wyższe lub w trakcie studiów (preferowane kierunki: informatyka, matematyka lub pokrewne); doświadczenie w zarządzaniu...

    Fujitsu Technology Solutions Sp. z o.o.

    wielkopolskie /


    Service Process Leader for Service Request & Catalogue Mgt with German

    Process Management Ensuring the process is executed appropriately at each described step Ensuring the appropriate inputs/outputs are being produced Delivery of the process related trainings Ensuring process awareness in the Team, Business Units and other...

Więcej ofert pracy

Podobne oferty pracy

  • Aont

    małopolskie / Kraków


    Data Administrator with German

    You’re well-organized, speak good English and German and want the chance to develope yourself in a corporate environment? Do you enjoy working with data in Excel files and making sure everything’s correct? If yes, then read on. We are looking for...

  • IT CONNECT Sp. z o.o.t

    mazowieckie / Warszawa


    Specjalista ds. Zarządzania Bazą Dostawców

    Poszukujemy pracownika na stanowisko Specjalisty ds. Zarządzania Bazą Dostawców, do 10-osobowego zespołu w strukturze Zakupów, który zajmuje się działaniami wspierającymi dla Kupców i Menadżerów Zakupów. Zadania: Administrowanie bazą...

  • Politechnika Wrocławskat

    dolnośląskie / Wrocław


    Specjalista / Specjalistka

    Zakres obowiązków: tworzenie dedykowanych rozwiązań bazodanowych w oparciu o technologie informatyczne na potrzeby Działu i jednostek współpracujących w zakresie budżetu i eksploatacji nieruchomości, projektowanie struktury danych i interfejsu...