Manager (m/f/d) Regulatory Affairs / GDP Quality Assurance

vor 4 Wochen

Munich, Bayern, Deutschland Gilead Sciences, Inc. Vollzeit

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site $) to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

Job Description

Manager (m/f/d) Regulatory Affairs / GDP Quality Assurance

For our German commercial affiliate we are looking for an experienced Manager (m/f/d) Regulatory Affairs / GDP Quality Assurance.

The role is office based in Martinsried, Munich and reporting to the Director, Regulatory Affairs.

General Responsibilities

  • Maintenance and improvement of the existing German QMS including implementation of relevant international Procedural Documents (PDs) within Gilead Sciences Germany.
  • Supports local Gilead representative as required by local law e.g. QA RP, GDP RP according to the German Drug Act § 52a "Großhandelsbeauftragter".
  • Manages interactions, negotiations, and communication with local Supervisory and Health Authorities and acts as point of contact for the local Supervisory and Health Authorities for specific quality topics.
  • Supports compliance with local law and regulation and consistency with global PDs for QA matters such as acting as a subject matter expert or audit / inspection lead within the affiliate, supporting essential licenses, contracts and agreement are in place and falsified/counterfeit products, stock outs and recalls are managed optimally.
  • Provide QA expertise to relevant parties as required.
  • Supports on regulatory maintenance activities for relevant medicinal products and other regulatory tasks.

Detailed description:

Quality Assurance tasks

  • Contributes to the continuous improvement of the QMS
  • Supports local Gilead representative as required by local law e.g. GDP RP, RP QA, etc
  • Focus on the management of quality of records
  • Manages the implementation and maintenance of initial & continuous training programs
  • Manages sample requests from local Supervisory Authority
  • Manages suppliers & customers qualification
  • Contributes to the approval of any subcontracted activities that have impact on GDP
  • Manages and performs self-inspections, audits as well as authority inspections and manages corrective and preventive actions
  • Prepares for and conducts vendor audits
  • Keeps appropriate records of any delegated duties
  • Supports decision making on final disposition of returned, rejected, recalled or falsified products
  • Supports approval of returns to saleable stock
  • Support or management of quality defects, customer complaints, falsified or counterfeit products, batch recalls and stock out as required
  • Supports that any additional requirements imposed on certain products by national law are adhered to
  • Contributes to the maintenance of the GDP license and manages the maintenance of Quality Agreements
  • May take a leadership role in conducting risk assessments on specific local regulatory issues
  • Helps prepare the Company for major changes in regulatory legislation

Regulatory Affairs tasks

  • Manages or prepares regulatory submissions to local Health Authorities, including variations, safety reports, risk minimization measures, Dear Healthcare Provider Communications, compassionate use as well as clinical trial applications and amendments as applicable, which may require interaction with departments outside ofRA
  • Ensure compliant labeling for Gilead medicinal products and manage timely updates
  • Provide operational support to local Regulatory Team with creation, review and release of German Compendia and Basistext

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site $) to apply for this job.


  • EMEA Senior Regulatory Affairs Manager

    vor 4 Wochen

    Munich, Bayern, Deutschland Proclinical Vollzeit

    Proclinical is on the lookout for a Senior Regulatory Affairs Manager. In this role, you will be responsible for developing and implementing regional regulatory strategies for the development, registration, commercialisation, and lifecycle management of assigned products/projects in the EMEA region. You will also manage affiliate level local Regulatory...

  • QA Quality Assurance Lead Munich Germany

    vor 3 Wochen

    Munich, Bayern, Deutschland Nexus Jobs Limited Vollzeit

    Job Description QA Quality Assurance Lead Munich Germany The Quality Assurance Lead must have at least 5 to 10 years experience in systems testing. Must have the ability to impose assertiveness and leadership qualities with clear a demonstration of leading the quality assurance processes and transformation. You will be driving teams towards change and...

  • Quality Assurance Representative Product Delivery, EAL

    vor 16 Stunden

    Munich, Bayern, Deutschland EPI Europrop International GmbH Vollzeit

    EPI Europrop International GmbH is responsible for the design, development, manufacturing, delivery and logistic support of the TP400-D6 engines for the A400M aircraft. The company, headquartered in Munich, was founded in 2002 by the four shareholders Industria de Turbo Propulsores S. A. U (ITP AERO), MTUAero Engines AG, Rolls-Royce plc. and SAFRAN Aircraft...

  • Quality Manager Software

    vor 2 Wochen

    Munich, Bayern, Deutschland ZEISS Gruppe Vollzeit

    Your RoleSupport of quality management activities in an interdisciplinary project team for software-only products in the medical environment.Analyze and review the product documentation, as well as approve and contributing product-specific and quality-oriented feedback, thereby ensuring the process-compliant development of the software products.Drive and...

  • Supply Chain Manager

    vor 4 Wochen

    Munich, Bayern, Deutschland Scienta Vollzeit

    EinleitungOur client, a rapidly growing biotech company based in Munich, with a commitment to excellence and a passion for cutting-edge research, are seeking a talented Supply Chain Manager to join their dynamic team. The successful candidate will be responsible for managing the end-to-end supply chain process, ensuring efficient procurement, production,...

  • Senior Manager Regulatory Reporting

    Vor 7 Tagen

    Munich, Bayern, Deutschland Deloitte Germany Vollzeit

    Senior Manager Regulatory Reporting / Bankenumfeld (m/w/d) Du willst im BereichRisk Advisory – Financial Industry Risk & RegulatoryFinanzdienstleistern helfen, Risiken besser zu managen? Unser Team unterstützt umfassend in allen Phasen des Geschäftsprozesses und kombiniert gezielte Erfahrung, tiefes technisches Wissen, führendes Branchen Know-how und...

  • Senior Manager Regulatory Reporting

    vor 4 Wochen

    Munich, Bayern, Deutschland Deloitte Germany Vollzeit

    Senior Manager Regulatory Reporting / Bankenumfeld (m/w/d) Du willst im BereichRisk Advisory – Financial Industry Risk & RegulatoryFinanzdienstleistern helfen, Risiken besser zu managen? Unser Team unterstützt umfassend in allen Phasen des Geschäftsprozesses und kombiniert gezielte Erfahrung, tiefes technisches Wissen, führendes Branchen Know-how und...

  • Quality Manager Software

    vor 2 Wochen

    Munich, Bayern, Deutschland ZEISS Gruppe Vollzeit

    locationsMünchenFull timeposted onPosted 20 Days Agojob requisition idJR_1032925Your RoleAnalyze and review the product documentation, as well as approve and contributing product-specific and quality-oriented feedback, thereby ensuring the process-compliant development of the software products.Drive and coordinate risk management activities according to ISO...

  • Data Quality Governance Manager

    Vor 4 Tagen

    Munich, Bayern, Deutschland Raiffeisen Bank International AG Vollzeit

    Data Quality Governance Manager -Professional (f/m/x)Welcome to the heart of data-driven banking excellenceOur Group Data Governance team is a vital component of the Group Risk Data & Regulatory Reporting Division, focused on the critical realms of BCBS 239 and Data Quality Standards. As a Data Quality Governance Manager, you'll be at the forefront of our...

  • Group Regulatory Compliance Officer

    Vor 4 Tagen

    Munich, Bayern, Deutschland Raiffeisen Bank International AG Vollzeit

    Group Regulatory Compliance Officer (f/m/x)The Group Regulatory Compliance Unit, a newly established department within the Group Regulatory Affairs division, is responsible for developing and implementing a comprehensive framework, policies, and procedures to effectively monitor, assess, and mitigate regulatory compliance risks across the RBI Group. Join us...

  • Supplier Quality Manager

    vor 1 Monat

    Munich, Bayern, Deutschland Data Modul AG Vollzeit

    DATA MODUL ist einer der weltweit führenden Spezialanbieter für professionelle, industrielle Display-, Touch-, Embedded-, Monitor- und Panel-PC Lösungen. Zur Verstärkung unseres Qualitätsmanagement-Teams am Standort Weikersheim suchen wir zum nächstmöglichen Zeitpunkt einen SUPPLIER QUALITY MANAGER (m/w/d) in Vollzeit.

  • Regulatory Reporting, AVP

    vor 1 Woche

    Munich, Bayern, Deutschland State Street Vollzeit

    Who we are looking for:You will be joining the Regulatory Reporting team in the Munich Office, where the Regulatory Reporting is being overseen for EMEA. Regulatory Reporting makes sure that SSBI Intl. GmbH sends reports to local and global supervisors in time and quality.Join us if making your mark in the financial services industry from day one is a...

  • Group Regulatory Reporting Specialist

    Vor 4 Tagen

    Munich, Bayern, Deutschland Raiffeisen Bank International AG Vollzeit

    Group Regulatory Reporting Specialist (f/m/x)The newly created division Group Risk Data & Regulatory Reporting acts as group wide responsible center of competence for regulatory reporting, data privacy, central hub for unified and comprehensive risk data related matters and data governance as well as driving the risk business architecture.You're dying to get...

  • Senior Manager Data Governance

    vor 4 Wochen

    Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Passion for innovation. Compassion for patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect...

  • Junior / Professional Regulatory Reporting Specialist (f/m/x)- limited for 1 year

    vor 15 Stunden

    Munich, Bayern, Deutschland Raiffeisen Bank International AG Vollzeit

    Junior / Professional Regulatory Reporting Specialist (f/m/x)- limited for 1 yearThe newly created division Group Risk Data & Regulatory Reporting acts as group wide responsible centre of competence for regulatory reporting, central hub for unified and comprehensive risk data related matters as well as driving the risk business architecture. We search for...

  • Part-Time Professional Regulatory Credit Risk Manager

    vor 1 Tag

    Munich, Bayern, Deutschland Raiffeisen Bank International AG Vollzeit

    Part-Time Professional Regulatory Credit Risk Manager (f/m/x)- >= 20 hours WeeklyThe Group IRB Coordination department operates within the Group Risk Controlling division. Our primary role is to serve as the central communication hub with banking regulators concerning internal capital adequacy models for credit and market risk. Additionally, we have the...

  • Consultant Regulatory Advisory

    Vor 7 Tagen

    Munich, Bayern, Deutschland Deloitte Germany Vollzeit

    Du willst im Bereich Risk Advisory – Financial Industry Risk & Regulatory Finanzdienstleistern helfen, Risiken besser zu managen? Unser Team unterstützt umfassend in allen Phasen des Geschäftsprozesses und kombiniert gezielte Erfahrung, tiefes technisches Wissen, führendes Branchen Know-how und ein umfangreiches Verständnis von regulatorischen...

  • Consultant Regulatory Advisory

    vor 4 Wochen

    Munich, Bayern, Deutschland Deloitte Germany Vollzeit

    Du willst im Bereich Risk Advisory – Financial Industry Risk & Regulatory Finanzdienstleistern helfen, Risiken besser zu managen? Unser Team unterstützt umfassend in allen Phasen des Geschäftsprozesses und kombiniert gezielte Erfahrung, tiefes technisches Wissen, führendes Branchen Know-how und ein umfangreiches Verständnis von regulatorischen...

  • Process Improvement Manager, CX, SC Quality, EU ATS CX

    vor 4 Wochen

    Munich, Bayern, Deutschland Amazon Vollzeit

    Amazon strives to be Earth's most customer-centric company where people can find and discover virtually anything they want to buy online. At Amazon, delivering great experiences for our customers is top priority and to this end, our team strives to make our processes robust enough to meet the high bar on customer experience both on quality and speed of...

  • QC Manager In-vitro-Diagnostik w/m/d

    vor 2 Wochen

    Munich, Bayern, Deutschland SCHLAGHECK + RADTKE Executive Consultants GmbH Vollzeit

    Inhabergeführt, wirtschaftlich/technisch unabhängig, hoch profitabel, schnelle Entscheidungen, eine loyale, sehr qualifizierte, erfahrene und dennoch junge Belegschaft. Es sind diese und zahlreiche weitere Gründe, weshalb unser Auftraggeber mit seinen 198 Mitarbeitern heute als Marktführer für klinische Routinediagnostik mit international sehr guter...