Head of Compliance

vor 2 Monaten

Marburg, Deutschland CSL Behring Vollzeit

For our Value Stream Filling in Marburg we are currently looking for a

Head of Compliance (m/f/x) - Deviation Management

R-243483

Fulltime / permanent

The job incumbent is a key player in the Value Stream both for critical deviation investigations as well as in internal, customer and regulatory audits. The main responsibility of the role is to proactively drive and improve cGMP compliance and a best in class Right First Time (RFT) approach (deviation and CAPA management, data trending and analysis, training, SOPs, change control) within the respective Value Stream. The role might act as Compliance representative/SME on behalf of the Value Stream in projects or other initiatives. The compliance to relevant Global Quality Policies should be ensured while the respective SOPs and/or working instructions are continuously monitored to be well compliant, if necessary to be revised accordingly.

Tasks & Responsibilities:

  • Strong leadership while motivating, developing and leading the team according to CSL values and principles.
  • Leading/coordination of complex deviations, identifying correct root causes (RC) and smart, effective CAPAs to avoid any re-occurrence of deviations. Compilation of deviation reports and risk assessments ready to be approved by QA.
  • Performing data analysis and trending as a tool to identify potential compliance/process issues (e.g. IPC warning limits excursions, drop in yields) in a proactive manner, as a tool to identify potential opportunities for process improvements and/or to understand root causes of more complex compliance/process issues to initiate an appropriate remediation.
  • Ensuring optimal inspection readiness in the Value Stream Fill. Preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required
  • Maintaining GMP training and adequate training status to ensure a compliant production (cGMP, EHS)
  • Might act as compliance representative/SME on behalf of the Value Stream in projects or other initiatives.
  • Initiate, coordinate and/or assessment of change controls. Ensure a compliant RTO (release to operation).
  • Approval of production protocols according to §14 AMG (German Medicines Act)

Education & Requirements:

  • Master degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
  • 5+ years of professional experience in the pharmaceutical/biotech industry with specific knowledge in Quality, cGMP compliance, deviation management and aseptic processes including 3+ years’ leadership/team management experience
  • Proofed experience in occupational safety and continuous improvements methods
  • Experienced in inspection situations with authorities (e.g. US FDA , Local German Health Authorities/ Regierungspräsidium)
  • A Lean Six sigma Green Belt training is favorable

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring

  • Head of Compliance

    vor 5 Monaten

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    For our Value Stream **Base Fractionation** Marburg we are looking for a **Head of Compliance (f/m/d) - R-208811** (fulltime/ permanent/ non-tariff/ location: Marburg) Position Purpose The main responsibility of the role is to drive and maintain Quality Assurance systems to ensure cGMP compliance and a best in class Right First Time (RFT) approach...

  • Head of Compliance Expert

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland CSL Behring Vollzeit

    Job SummaryCSL Behring is seeking a skilled Head of Compliance to drive and improve cGMP compliance and a best in class Right First Time (RFT) approach within the Value Stream Fill.The ideal candidate will have a strong background in quality, cGMP compliance, deviation management, and aseptic processes, with at least 3 years of leadership experience.Key...

  • Head of Compliance

    vor 2 Monaten

    Marburg, Deutschland CSL Behring Vollzeit

    For our Value Stream Filling in Marburg we are currently looking for aHead of Compliance (m/f/x) - Deviation ManagementR-243483Fulltime / permanentThe job incumbent is a key player in the Value Stream both for critical deviation investigations as well as in internal, customer and regulatory audits. The main responsibility of the role is to proactively drive...

  • Head of Compliance

    vor 2 Monaten

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    For our Value Stream Filling in Marburg we are currently looking for a **Head of Compliance (M/F/x)**: R-243483 Fulltime / permanent The job incumbent is a key player in the Value Stream both for critical deviation investigations as well as in internal, customer and regulatory audits. The main responsibility of the role is to proactively drive and improve...

  • Head of QPPV Office and PV Intelligence

    vor 6 Monaten

    Marburg, Deutschland CSL Vollzeit

    For our GSPV department, we are looking for a Head of QPPV Office and PV Intelligence (m/f/x) R-233736 Fulltime / permanent / non-tariff  The Opportunity As Head of QPPV Office and PV Intelligence you will be responsible for the direction and management of the QPPV office team and the PV Intelligence function to ensure accurate...

  • Senior Director, Head Global Pv Compliance

    Vor 7 Tagen

    Marburg an der Lahn, Deutschland CSL Behring Vollzeit

    For our **Global Safety and Pharmacovigilance **department, we are looking for a **Senior Director, Head Global PV Compliance (M/F/x)**: R-246568 Fulltime / permanent/ non-tariff As Senior Director, Head Global PV Compliance you will be a key leader and influencer who drives cross-functional strategies to demonstrate a healthy CSL PV System for CSL...

  • Inhouse Head of SAP

    vor 3 Monaten

    Marburg, Deutschland Nothegger Personalberatung Vollzeit

    FirmenbeschreibungMein Kunde ist führendes, produzierendes Unternehmen aus der Technologiebranche, östlich von Marburg. Das innovative Unternehmen agiert weltweit und gilt als "Hidden Champion" in seinem Segment. Um die SAP-Mannschaft des attraktiven Arbeitgebers voranzubringen, suchen wir zum nächstmöglichen Zeitpunkt einen erfahrenen und motivierten...

  • Kapitalprojektmanagerin - Head Marburg

    Vor 6 Tagen

    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

    Wir suchen für unseren Bereich Engineering in Marburg eine Kapitalprojektmanagerin als Head, die unsere Projekte effizient und erfolgreich umsetzt.Beschreibung der PositionKoordinieren Sie unsere Projekte und Ressourcen zur Durchführung von Kapitalprojekten in Marburg. Die Rolle ist verantwortlich für die Steigerung der Effizienz unserer Programme,...

  • Head of Training

    vor 6 Monaten

    Marburg, Deutschland Schwabe Group Vollzeit

    Die OTX Force GmbH ist die ei­gen­stän­di­ge Ver­triebs­ge­sell­schaft der be­reits in fünf­ter Ge­ne­ra­ti­on ge­führ­ten Un­ter­neh­mens­grup­pe Dr. Will­mar Schwa­be – dem welt­weit füh­ren­den Ex­per­ten in der Er­for­schung, Ent­wick­lung und Her­stel­lung von pflanz­li­chen Arz­nei­mit­teln. Als Teil des...

  • Head of Training

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland Schwabe Group Vollzeit

    Wir suchen für unseren Bereich Commercial Operations eine/nHead of Training & Learning (m/w/d)Die Vollzeitstelle ist unbefristet.Ihre HauptaufgabenSie entwickeln und steuern Trainingsprogramme für eine Arzt-, eine Apotheke- sowie eine Hybrid- (Heilpraktiker / Apotheke) Außenstellenlinie.Sie sind verantwortlich für die Konzeption und Erstellung von...

  • Project Delivery Head Marburg m/w/x

    vor 5 Monaten

    Marburg, Deutschland CSL Vollzeit

    Für unseren Bereich Engineering in Marburg suchen wir aktuell einen Direktor:in Project Delivery – Head Marburg (m/w/x) – R- 234641 Vollzeit / befristet / AT Internes Ausschreibungsende: 24.06.2024 Direktor:in Project Delivery - Head Marburg ist verantwortlich für die Koordination von Projekten und Ressourcen zur Durchführung von...

  • Head (m/f/d) Quality and Materials Engineering

    vor 3 Monaten

    Marburg, Deutschland GULP – experts united Vollzeit

    On behalf of our business partner, we are currently looking for a qualified Head of Quality and Materials Engineering (m/f/d) for direct placement . Use our service as a springboard into the team of a renowned automotive supplier in Marburg . Apply directly online now - or contact us by phone or e-mail. By the way: We value equal opportunities...

  • Head of Projects

    vor 5 Monaten

    Marburg an der Lahn, Deutschland Pharmaserv GmbH Vollzeit

    **Pharmaserv Logistics**: Als Pharmaserv Logistics sind wir Pioniere in der GMP-konformen Produktionsversorgung sowie Experten für die Lagerung, Verpackung und Distribution von temperatursensiblen Arzneimitteln für Unternehmen der Biotechnologie - und Pharmaziebranche. Einige der weltweit größten Pharmaunternehmen unterstützen wir dabei, Leben zu...

  • Payroll Manager

    vor 6 Monaten

    Marburg, Deutschland CSL Vollzeit

    The Payroll Manager position is responsible for managing a team that processes a large volume, multiple entity and complex payrolls. You are the main contact and SME for the payrolls you support. You will work with Payroll Vendors and TLM Administrators to support your team in processing of payroll, providing all appropriate payroll input, ensuring...

  • Spezialist/in Compliance

    vor 5 Monaten

    Marburg, Deutschland CSL Vollzeit

    Für unseren Value Stream Filling in Marburg suchen wir aktuell eine/n Spezialist/in (m/w/x) Compliance – R-236407 (Vollzeit / unbefristet / Tarif) Ausschreibungsende: 09.07.2024 Aufgaben Bearbeitung, Koordination bzw. Erstbewertung von komplexen Abweichungen im Verantwortungsbereich Evaluierung, Abstimmung und Umsetzung von komplexen CAPAs zur...

  • Operations & Process Governance Lead- Legal Operations

    vor 6 Monaten

    Marburg, Deutschland CSL Vollzeit

    The Opportunity This is an Associate Director level role. Reporting to the Global Head Legal Operations, you will oversee, design, and implement governance structures, procedures, and protocols that optimize the functioning of the wider Legal department. You will ensure that the department operates efficiently, transparently, and in compliance with...

  • Senior Director Clinical Trial Supply

    vor 6 Monaten

    Marburg, Deutschland CSL Vollzeit

    To strengthen our Supply Chain department in Europe, we currently hire a Senior Director Clinical Trial Supply (m/w/x) R-229882 Fulltime / permanent / Level 10 This is a senior leadership role within the CSL Enterprise Supply Chain and is responsible for the strategic leadership and delivery of all services within the scope outlined below,...

  • Global Marketing Head

    vor 1 Monat

    Marburg an der Lahn, Hessen, Deutschland Siemens Healthcare Diagnostics Products GmbH Vollzeit

    Key ResponsibilitiesAs the Head of Global Marketing for the Hemostasis product line, you will be responsible for driving business success and maximizing revenue growth in this highly competitive market.Key Accountabilities:Develop and execute strategic marketing plans to sustain and maximize revenue growth in Hemostasis marketsLead cross-functional teams to...

  • Head of Trainingslösungen

    vor 4 Wochen

    Marburg an der Lahn, Hessen, Deutschland Schwabe Group Vollzeit

    Die Schwabe Group ist eine der führenden Unternehmen in der Forschung, Entwicklung und Herstellung von pflanzlichen Arzneimitteln. Als Teil des inhabergeführten Familienunternehmens mit weltweit 4.000 Angestellten und Sitz in Karlsruhe betreut die Schwabe Group Ärzte und Apotheker in Deutschland und versorgt die relevanten Kundengruppen mit für die...

  • Head of Fresh Food Counters

    Vor 6 Tagen

    Marburg, Deutschland REWE Vollzeit

    **Ort:** 35037 Marburg | **Vertragsart:** Vollzeit, unbefristet | **Job-ID:** 851026 ![](https:hr.rewe- group.comPRIMUSRecruitingHeaderbilderrewe_pierre_bereichsleiter_markt_frischetheke.jpg) **Was du bei uns bewegst:** Die Frischetheke ist das Herz unserer **REWE Selcuk Memoglu oHG**. Mit deinem Fachwissen und einer wertschätzenden Führungskultur...