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

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 :

• 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
• 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 :

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