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 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...

  • Senior Director, Head Global Pv Compliance

    Vor 5 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...

  • 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...

  • 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...

  • Kapitalprojektmanagerin - Head Marburg

    Vor 3 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 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...

  • 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...

  • Head of Pharmacovigilance

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Viatris Vollzeit

    At Viatris, we're seeking a skilled professional to lead our pharmacovigilance efforts in Germany. As Head of Pharmacovigilance, you will be responsible for ensuring compliance with national regulatory authority requirements and Viatris standards.About the RoleLead the German pharmacovigilance department with 5 direct reports, overseeing quality control and...

  • Head of Market Risk Management

    vor 1 Monat

    Roth an der Our, Deutschland ING Luxembourg Vollzeit

    Your role & work environment The Head of Market Risk Management is a direct report to the Chief Risk Officer, responsible for managing the balance sheet risks of ING Luxemburg, in particular the Interest Rate Risks in the Banking Books and the Funding & Liquidity risks.The Head of Market Risk Management oversees a department of +/- 8 risk experts working...

  • Head of Project Engineering

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    ÜberblickWir suchen einen erfahrenen Head of Project Engineering für unseren Entwicklungs- und Produktionsstandort in Pfaffenhofen/Ilm.Die HerausforderungAls Head of Project Engineering werden Sie die Leitung des gesamten Lebenszyklus von CAPEX-Projekten im Pharmaumfeld übernehmen. Dazu gehören die Entwicklung und Umsetzung von Strategien zur...

  • 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...

  • Head of Clinical Development

    vor 3 Monaten

    Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Building on our legacy of innovative treatments for a range of cardiovascular, renal and metabolic conditions, our R&D strategy takes a holistic view of the needs of people with metabolic diseases such as diabetes, who often have multiple, related conditions. We are pursuing the next wave of innovative medicines for obesity, kidney and...

  • Head of Laboratory

    vor 2 Monaten

    Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Take advantage of your experience, lead an agile team of experienced technicians and scientists, and actively contribute to international **research **project teams to assure long-term profitability of a globally leading and family-owned pharmaceutical company. As a Head of Laboratory, you will combine a strong pharma industry background...

  • Head of Laboratory

    vor 2 Monaten

    Biberach an der Riß, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Work at the forefront of pharmaceutical development! Join our team as Head of Laboratory in our Pharmaceutical Development Biologicals department, driving our automation and lab system support. This pivotal role offers a unique opportunity to collaborate with various departments, including our newly established Development Biologicals...

  • Head of Academy

    vor 4 Wochen

    Neumarkt in der Oberpfalz, Bayern, Deutschland DEHN SE Vollzeit

    Head of AcademyWir suchen eine erfahrene Führungskraft, die unsere Schulungskonzepte entwickelt und umsetzt. Als Head of Academy sind Sie verantwortlich für die Entwicklung von Schulungskonzepten, die sowohl digital als auch persönlich durchgeführt werden und auf die verschiedenen Kundengruppen weltweit zugeschnitten sind.Ihre AufgabenSie entwickeln und...

  • Head of Market Risk Management Expert

    vor 4 Wochen

    Roth an der Our, Deutschland ING Luxembourg Vollzeit

    About the RoleThe Head of Market Risk Management is a key position within ING Luxembourg, responsible for managing the balance sheet risks of the organization. This includes identifying, assessing, and mitigating risks associated with interest rate and funding & liquidity risks.The successful candidate will oversee a team of risk experts and work closely...

  • Head of HR Retail Strategist

    vor 4 Wochen

    Geislingen an der Steige, Baden-Württemberg, Deutschland WMF Vollzeit

    Head of HR RetailWir suchen einen erfahrenen Head of HR Retail, der unsere Retail-Führungskräfte strategisch unterstützt und die Transformation unseres HR-Bereichs vorantreibt.VerantwortlichkeitenBetreuung des Retail-Bereichs in sämtlichen PersonalthemenFührung eines Teams (HRBP & HR Specialsts)Überwachung und Steuerung aller HR-relevanten KPIs und...

  • Officer Compliance

    vor 1 Monat

    Roth an der Our, Deutschland Cargolux Airlines International SA Vollzeit

    TASK RESPONSIBILITIES:Manage day-to-day operations of the Cargolux (CV) Compliance Program Design, implement & monitor effective measures aiming to manage adequately Compliance related risks in Cargolux linked to the topics of Anti-Corruption, Anti-Trust, Fraud and AML, GDPR. Additionally, some involvement in Export Controls affairs may be necessary.Work...

  • Head of Market Risk Management Expert

    vor 4 Wochen

    Roth an der Our, Deutschland ING Luxembourg Vollzeit

    About the RoleThe Head of Market Risk Management is a key position within ING Luxembourg, reporting directly to the Chief Risk Officer. This role is responsible for managing the balance sheet risks of ING Luxembourg, with a focus on Interest Rate Risks in the Banking Books and Funding & Liquidity risks.Key ResponsibilitiesManage Interest Rate Risks in the...