Company Description

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

A career where all your skills can come into play? We Offer That.

A task that meets your passionate approach? 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!

In our Operations Team at Ludwigshafen site you will join a team of talented people and experienced experts in the manufacturing and global distribution of our approved and pipeline products – working with some of the most advanced technologies in the world.

Develop your expertise and join our team as Manager Manufacturing Quality Assurance (all genders).

Make an impact:

As Manager Manufacturing Quality Assurance, you will support the Operations Unit in quality related topics and leading the respective group.

You take over responsibility for the compliance and improvement of the processes as sampling of incoming goods, review of manufacturing batch records according to the current GMP requirements (AMG, AMWHV, GMP) and AbbVie internal requirements and medical device quality assurance according to ISO 13485and QSR FDA.

As interface with Supply Chain Management and Planning you ensure timely market supply, timely sampling of incoming goods like raw materials, bulk and packaging materials, timely review of manufacturing documentation and timely review of device history records and batch release.

You develop the team tfocus towards shopfloor integrated Quality function and drive continuous improvement of the team competence regarding the current GMP- and legal work-safety requirements.

This means you:

• Compile and work on local and global procedures and documents including membership of AbbVie Center of Excellence

• Conduct QA assessment of nonconformities and complaints as well as the determination of appropriate measures for medical devices

• Build performance monitoring processes and tools, assure that targets are met in the scope of organizational strategic priorities, define resources needed to run planned volumes

• Coordinate and align with internal and external stakeholders (e.g. supply chain management, production, suppliers) to ensure product availability and secure continuous market supply.

• Identify opportunities and looking beyond own discipline for improvement in terms of resources usage, cost savings, etc.

• Participate in Quality project coordination for performance improvement as well as for site compliance improvement in line with site Business Excellence processes.

• Drive business process simplification and innovation culture in QA/QC organization, keeping updated with technological innovations, benchmarking, enabling cost/benefit evaluations and business case definitions, to implement innovation through sustainable projects.

• Provide leadership for subordinate team.

• Participate, as subject matter expert in scope of function, in audits and inspections.

• Act as key contact for GxP relevant questions at the site in scope of the function.

Qualifications

This is how you make a difference:

• Master’s degree in information technology, Engineering, Chemistry / Pharmaceutical Chemistry / Pharmacy or equivalent

• 8+ years of experience in Operations and/or Quality Pharma or Medical Device

• 5+ years of experience in people leadership

• Knowledge of cGMP regulations and agencies’ expectations

• Experience in Pharma inspections (desirable)

• High degree of self-motivation, proactivity, and efficient results-oriented way of working

• Passionate for process improvement and performance

• Sound understanding of ERP system processes and key system functions related to Quality Management with throughout and proven experience of SAP S4/HANA (PP, MM, WM, QM)

• Excellent communication and presentation skills, organizational and motivational talent

• Business Fluent, written and spoken, in German and English

  What we offer:

• 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 Ab bVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond!

Sounds like the perfect career opportunity for you? We look forward to receiving your application. All you need is a complete CV – anything else will be discussed in person, where possible, if general suitability is determined.

Have questions? Email us at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.