GDP Quality Assurance at Gilead Sciences

Munich, Bavaria, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Experienced in Regulatory Affairs / GDP Quality Assurance
Knowledge of German Drug Act § 52a “Großhandelsbeauftragter” and ability to support the GDP Responsible Person (RP)
Familiarity with Good Distribution Practice (GDP) and wholesale activities
Understanding of Quality Management Systems (QMS) and international Procedural Documents (PDs)
Ability to manage QA projects and participate in global QA workstreams
Experience in interactions, negotiations, and communication with local Supervisory and Health Authorities
Expertise in local laws, regulations, and global PDs for QA matters
Capable of acting as subject matter expert, audit/inspection lead, or deputy GDP RP/QA RP
Skills in managing suppliers, customers qualification, deviations, CAPAs, self-inspections, audits, and authority inspections
Availability for office-based role in Martinsried, Munich

Responsibilities

Maintenance and improvement of the German Quality Management System (QMS), including implementation of relevant international Procedural Documents (PDs), with focus on GDP and wholesale activities
Support the GDP Responsible Person (RP) according to German Drug Act § 52a
Manage QA projects and participate in global QA workstreams
Manage interactions, negotiations, and communication with local Supervisory and Health Authorities; act as point of contact for specific quality topics
Support compliance with local law and regulation, consistency with global PDs, essential licenses, contracts, agreements, falsified/counterfeit products, stock outs, and recalls
Provide QA expertise to relevant parties as required
Support regulatory maintenance activities for relevant medicinal products and other regulatory tasks
Drive continuous improvement of the QMS
Support local Gilead representative roles (e.g., GDP RP, RP QA)
Manage quality of records, initial & continuous training programs, sample requests from authorities, suppliers & customers qualification, deviations and CAPAs
Contribute to approval of subcontracted GDP-impacting activities
Manage and perform self-inspections, audits, authority inspections, and related CAPAs; prepare for and conduct vendor audits
Keep records of delegated duties
Support decision making on final disposition of returned, rejected, recalled, or falsified products; approve returns to saleable stock
Support or manage quality defects, customer complaints, falsified/counterfeit products, batch recalls, and stock outs
Ensure adherence to additional national law requirements on products
Contribute to maintenance of GDP license and Quality Agreements
May take a leadership role

Skills

Regulatory Affairs

GDP

Quality Assurance

QMS

Good Distribution Practice

QA Projects

German Drug Act

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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