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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The job that helps you get ahead in life. Moving mountains together.
Welcome to AbbVie! As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrow's unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place!
We are hiring for our site in Ludwigshafen/Rhine a highly motivated Manager Qualification and Validation (all genders) to support our diverse team.
In this role you take the responsibility for Quality Assurance in qualification and validation projects leading the respective QA group in following areas:
- Qualification of equipment for Quality Control and pharmaceutical manufacturing
- Validation of processes incl. cleaning validation
- Validation of operational systems incl. IT-systems
- QA-Oversight of metrology and preventive maintenance
- Data governance – Process owner at LU site
Managing, co-ordination, implementation and active participation in the site Validation Program you ensure team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines at all times. You are responsible for presenting and taking ownership of your area during regulatory inspections and corporate audits.
In this role you:
- Generate / maintain the Validation Master Plans, Project Validation Plans, Protocols and final reports to cGMP standard.
- Provide leadership for subordinate employees.
- Timely implement projects
- Ensure site compliance with cGMP and applicable regulations (e.g., GAMP, 21 CFR Part 11, EU GMP Annex 11), and compliance with AbbVie requirements.
- Ensure Quality performance of equipment, systems, and processes; meet highest product Quality standards and performance targets, improve the site processes.
- Act as key contact for GxP-relevant questions at the site in scope of the function.
- Participate in authority inspections and customer audits as subject matter expert
Qualifications
That’s how you make a difference:
- Master’s degree in (Pharmaceutical) Engineering / Natural Sciences or equivalent
- 5+ years of experience in the qualification and validation area, in the pharmaceutical or any comparably regulated industry
- Minimum 2-year experience in Pharmaceutical Quality
- Sound knowledge of cGMP regulation (EU/FDA) and agencies’ expectations
- Experience in Pharmaceutical inspections (desirable)
- Strong leadership skills with minimum 3-year experience in group leadership
- Passionate for performance and process improvement
- High degree of self-motivation, proactivity, and efficient results-oriented way of working
- German and English both business fluent
Here's how we can move mountains 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.
At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.
Any questions? Feel free to email us at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!
An internal application always requires a certain degree of transparency. So please remember when you want to inform the current manager about it. If there is any uncertainty on this subject Talent Acquisition (Hartmut Sperber) and colleagues on the Works Council will also be available for information. The position is remunerated with AT (depending on qualification and experience).
Additional Information
AbbVie is an equal opportunity employer and 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.
US & Puerto Rico only - to learn more, visithttps://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
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