Quality Assurance Manager (Quality Responsible Person) Germany

1+ years

Not Disclosed

Munich

10 Nov. 24, 2024

Job Description

Job Type: Full Time Education: MSc./M. Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The job description you provided is for a Quality Assurance Manager position at Organon in Germany. This role also functions as the Quality Responsible Person (QRP) for the Wholesale Distribution Authorization (WDA) and will oversee quality activities for both Germany and Austria. Here’s a detailed breakdown:

Position Overview:

Role: Quality Responsible Person (QRP) and Manager for ensuring compliance with internal and external requirements related to wholesaling and distribution activities.
Primary Focus: Overseeing compliance with Good Distribution Practices (GDP) and ensuring the safety and quality of medicinal products.
Collaboration: High level of interaction with both internal stakeholders and local health authorities.

Key Responsibilities:

Quality Responsible Person (QRP):
- Serve as the QRP according to § 52a AMG and AM-HandelsV.
- Act as the primary point of contact for local health authorities regarding quality matters.
- Ensure compliance with local and EU regulations concerning GDP for medicinal products and medical devices.
Quality Management System (QMS):
- Creation, maintenance, and implementation of QMS procedures related to GDP.
- Oversee the handling of Product Quality Complaints (PQCs).
- Manage and ensure compliance with processes related to deviations, CAPAs, recalls, self-inspections, audits, change control, quality risk management, returns, destructions, customer and supplier qualification, counterfeit management, and serialization.
Training and Reporting:
- Develop and maintain local quality training programs.
- Ensure proper internal reporting and agency notifications, including stock-outs and administrative holds.
External Collaborations:
- Review and approve quality agreements with distributors and other contracted parties.
- Host and manage agency inspections.
- Supervise GDP activities and ensure compliance across distribution channels.
Continuous Improvement:
- Perform Management Quality Reviews and establish quality metrics to ensure ongoing quality improvements.
- Stay updated on relevant EU and local regulations and quality requirements.
Regional Collaboration:
- Support regional activities such as regional SOPs and collaboration with quality functions in other markets.

Required Education, Experience, and Skills:

Education: Master’s degree in Pharmacy or other life sciences (e.g., biology, medicine, chemistry).
Experience:
- Solid experience in a quality assurance role within the pharmaceutical industry.
- Previous experience as a Quality Responsible Person (QRP) or deputy is preferred.
- Extensive experience in interacting with health authorities.
Skills:
- Strong leadership, problem-solving, and communication skills.
- Fluency in both German and English.
- Experience managing quality processes, including deviations, CAPAs, and audits.

Additional Information:

Employee Status: Regular, full-time position.
Relocation: No relocation assistance provided.
VISA Sponsorship: Not offered.
Travel: Travel requirements not specified, but may involve some travel for inspections and audits.
Flexible Work: There may be the possibility for part-time work, subject to operational requirements.

Organon Overview:

Organon is a global healthcare company with a mission to improve health outcomes, especially for women and their families. Their focus is on women’s health, biosimilars, and health solutions that positively impact communities.

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Quality Assurance Manager (Quality Responsible Person) Germany

Job Description

Position Overview:

Key Responsibilities:

Required Education, Experience, and Skills:

Additional Information:

Organon Overview:

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