Company Description
Welcome to AbbVie!
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
In our Quality Assurance team in Ludwigshafen, you will join a group of experienced professionals dedicated to ensuring quality, compliance, and operational excellence across a complex commercial pharmaceutical environment. Working at the interface of local quality oversight, MAH responsibilities for centrally filed products in Europe, and cross-functional collaboration, you will help shape robust quality systems and drive continuous improvement. If you are passionate about leading teams, navigating regulatory complexity, and partnering with stakeholders across the business to enable compliant and efficient operations, we invite you to join us as Senior Manager CQA (all genders)!
Your Responsibilities:
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Providing leadership and oversight of quality compliance matters at an operational and regulatory complex commercial entity
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Oversight of quality at the affiliate level as well as MAH responsibilities for centrally filed products in Europe
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Integration and support of German regulations at the affiliate level for drugs, biologics, device and/or combination products
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Driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency
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Managing the Wholesale Distribution Authorization (WDA) and hosting internal, external and MoH inspections & audits in support of this licence
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Responsible for the management and oversight of a team including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues
Qualifications
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M.Sc. or B.Sc., preferably in a technical field
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5+ years of experience in Quality Assurance, Operations, or a regulatory environment
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Proven experience leading and managing teams, including setting priorities, coaching team members, and driving results through collaboration and accountability
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Business-fluent proficiency in both German and English is required
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Experience working in a GxP-regulated pharmaceutical environment is imperative
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Strong understanding of how Quality Assurance supports broader business objectives, with the ability to foster a culture of continuous improvement and leadership development
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Knowledge of regulatory requirements for complex finished products, including storage, distribution, product complaints, supplier management, risk management, and inspections
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Excellent stakeholder management skills, including collaboration with Regulatory, Commercial, and Site Manufacturing teams
Here's how we can grow together:
- with a diverse work environment where you can have a real impact
- with an open corporate culture
- with an attractive salary
- with an intensive onboarding process with a mentor at your side
- with flexible work models for a healthy work-life balance
- with a corporate health management that offers comprehensive health and exercise programs
- with company social benefits
- with a wide range of career opportunities in an international organization
- with top-tier, attractive development opportunities
- with a strong international network
Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.
Any questions? Feel free to email us at [email protected] – we look forward to hearing from you!
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
