VetJobs - The Leading Military Job Board

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) 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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.