Post Market Quality Lab Supervisor (all genders) - permanent in fulltime

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.

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 Post Market Quality Organization at the 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.  
 
Join our team as Post Market Quality Lab Supervisor (all genders).
 
As Post Market Quality Assurance Laboratory Supervisor you are responsible for leading the complaint laboratory analyst team. 

In this role you are considered a subject matter expert (SME) for complaint laboratory operations and will serve as a day-to-day resource for the team to support the group. The objective of this function is to ensure compliance with regulatory and corporate requirements, assure product quality and customer satisfaction, and develop and maintain operations within the laboratory aligned with quality systems and driving continuous improvement. You will work in AbbVie’s global quality organization to test complaint return samples in support of commercialized  product quality complaints. You represent the interface with internal and external AbbVie customers such as other PMQA teams, regulatory bodies (i.e. the FDA), product quality/TPMS,  manufacturing sites, technical support, and the commercial quality organization, regarding AbbVie product quality complaints.

 
Make an impact - being:

• responsible for management of Post Market Quality Assurance Complaint Sample Return lab, including personnel and product complaint documentation, and investigations.
  


• responsible for the operations and function of the laboratory group which includes lab safety management, training, GxP, metrics and timeliness, continuous improvement and project oversight.
  


• in charge of leading personnel in the application of Quality policies, procedures, projects, product launches, systems and may be required to assist with complaint handling based on business needs.
  


• the designer of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. You may be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
  


• responsible for developping staffing requirements, supervising a combination of exempt and nonexempt employees and ensure training and development plans are current and executed.
  


• accountable for making independent compliant decisions based on knowledge of regulatory requirements.
  


• in the driver seat for initiating, managing and executing projects to continuously improve the overall effectiveness of the department.
  


• responsible for maintaining  Data Integrity standards and assure GMP documentation standards.

This is how you can make a difference:

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
  


• at least 5 years experience in quality assurance, quality oversight or relevant experience.
  


• at least 3 years Supervisory experience, quality assurance experience preferred (solid understanding of GxP requirements)
  


• Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
  


• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
  


• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, combination and pharmaceutical products.
  


• Ability to utilize scientific education and leadership experience to support laboratory testing within a GMP environment to oversee personnel and product complaint return sample testing activities.
  


• Experience with working in both team setting, cross functionally and independently. 
  


• Project management experience and strong leadership ability, ability to communicate quality requirements effectively and timely and manage small to medium sized quality related projects.
  


• Strong oral and written communication skills needed.

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 AbbVie, 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!  

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.