AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio Further develop your expertise and join our team in Ludwigshafen as Senior Manager (all genders) Quality Operations (fulltime / permanent)
Core Job responsibilities: Assume full responsibility and accountability for Quality Operations and lead the respective Quality Assurance groups. Manufacturing QA: Line officers, batch record review Qualification and validation of equipment, processes, systems, infrastructure Oversight of metrology and preventive maintenance Data governance and data management Planning and scheduling of QC / QA processes Other main responsibilities Provide leadership for subordinate managers and employees Ensure site compliance with cGMP and applicable ISO regulations (e. g., ISO 13485) and compliance with AbbVie requirements Ensure Quality performance, meet highest product Quality standards and performance targets Act as key contact for GxP-relevant questions at the site Active participation in international workgroups and sharing best practices to foster continuous improvement Batch certification (desirable) Participation in authority inspections and customer audits
Master’s degree in Chemistry / Pharmaceutical Chemistry / Pharmacy or equivalent 8+ years of experience in pharmaceutical industry, preferably drug product Minimum 2-year experience in Pharma Quality Sound knowledge of cGMP regulation (EU / FDA) and agencies’ expectations Experience in Medical Device Quality (desirable) Ability to act as Qualified Person according to EU GMP (desirable) Experience in Pharmaceutical inspections (desirable) Strong leadership skills with minimum 3-year experience in leading large groups Passionate for performance and process improvement High degree of self-motivation, proactivity, and efficient results-oriented way of working Excellent communication and presentation skills, organizational and motivational talent Business Fluent, written and spoken, in German and English
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.