Qualified Person - Ludwigshafen am Rhein, Deutschland - ABBVIE

ABBVIE

Geprüftes Unternehmen

Ludwigshafen am Rhein, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

A career in which you can achieve more? We Offer That.
Looking for challenges where you can grow? We Offer That.
A career where all your skills can come into play? We Offer That.

Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow.

Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You've found the right place

Further develop your expertise and join our team as

Qualified Person (all genders) Clinical Supplies

in Ludwigshafen am Rhein.

That means:

Manage GxP inspection activities to assure that R&D quality system, manufacturing facilities, testing programs, clinical and preclinical study conduct, personnel and records in support of worldwide regulatory filings are able to demonstrate compliance to policies, procedures and applicable government regulations.
Influence and train inspection preparation teams comprised of a variety of technical experts.
Coordinate GxP preapproval inspection preparation activities for contract facilities utilized in support of regulatory filings.
Strategize corrective action plans and provide compliance support during implementation to ensure successful inspections.
Effectively communicate risks to management, both orally and in writing.
Quality Systems: Provide guidance and interpretation of Affiliate QA Policies and Procedures based on applicable requirements/regulations
Management of the global AbbVie R&D selfinspection program including organization of the global, internal audit schedule

This is how you can make a difference:

Bachelor's degree, preferably in physical science (e.g. Chemistry) life science (e.g. microbiology or biology) or pharmacy. Strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized technical fields.
Accreditation by a professional body desirable. Examples include American Society for Quality (ASQ) Certified Quality Manager (CQM) or Project Management Professional (PMP Certification.
Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory or Validation background in a regulated industry required.

Experience in two or more of the following areas:
Clinical Operations, Pharmacovigilance, manufacturing/testing of sterile dosage forms, biologics, liquids, solid dosages, active pharmaceutical ingredients or medical devices.

Thorough, documented understanding/knowledge of international GXP regulations. Knowledge of pharmaceutical drug development and clinical research processes.
Regulatory inspection experience preferably with direct agency inspector interaction.
Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
Strong project management skills are essential.
Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make difficult decisions, often at short notice.

What we offer you:
- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible work models for a healthy work-life balance
- corporate health management with comprehensive health and exercise programs
- corporate social benefits
- diverse career options in an international organization
- high-level, attractive career development opportunities
- a strong international network

At AbbVie, your individual contributions count - help us achieve more together. Be a part of it and grow with us - go above and beyond