Quality Assurance Manager EU

at  Life Molecular Imaging

Life Molecular Imaging GmbH (LMI) is a Germany-based Research and Development (R&D) organization focused on developing Positron Emission Tomography (PET) imaging solutions to diseases with high unmet medical need. As a division of the Life Healthcare Group, we are a fully integrated pharmaceutical company with research and development laboratories, access to a network of cyclotrons, radio-pharmacies and imaging facilities. Our vision is to build our position as an innovator and leading player in the Molecular Imaging field. We aim to create value for patients and physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life. For our approved PET tracer Neuraceq® (Florbetaben 18F) and our pipeline of tracers in clinical development we offer the following full-time position:

QUALIFICATION AND EXPERIENCE:

• University degree or comparable education in a science field (chemistry, biology, pharmacy or equivalent).
• Several years’ experience in QA in an EU/UK pharmaceutical environment preferably in radiopharmaceutical production, aseptic manufacturing, or contract manufacturing.
• Solid GMP background and experience working in a EMA/ MHRA regulated environment.
• Experience in conducting audits.

SKILLS

• Attention to detail and quality orientation.
• Excellent communication, interpersonal and organizational skills.
• Ability to work effectively in a team environment.
• Ability to travel 10% in EU/UK as needed.
• Open-minded, proactive, and motivating attitude.
• Familiar with Microsoft Office 365 programs.
• Demonstrated ability to become acquainted with customized software products.
• Fluency in English
  The position is based in our headquarters in Berlin or home-based in Europe. The development of the duties may require occasional travel to the headquarters in Berlin (Germany).
  If you want to become part of an entrepreneurial team, assume a wide range of responsibilities and your experience fits the above description, please send us your complete application (Cover letter detailing your interest in this position including your past relevant work experience & CV) as a pdf document to:
  Annekathrin Kirchner/ Human Resources
  Life Molecular Imaging GmbH
  Tegeler Str. 6-7
  13353 Berlin
  Germany
  https://life-mi.com

We are looking forward to receiving your application!

• The person counts, not the gender!

Life Molecular Imaging is committed to diversity, rejects discrimination and does not think in categories such as gender, ethnic origin, religion, disability, age or sexual identity.
Life Molecular Imaging GmbH is an Equal Opportunity Employer. We believe what we do and our culture of “More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment

• Qualify and monitor EU/UK contract manufacturers including assessment for suitability; compliance to the applicable GMP regulations and guidelines including:
• Handling deviations, OOS-results, change control requests, CAPAs and complaints,
• Performing and follow-up of GMP-audits at EU/UK contract manufacturing sites.
• Establish, review, and implement quality standards, specifications, parameters, analytical testing, manufacturing methods and validations in compliance with the applicable GMP regulations.
• Create and establish internal quality documents and standard operating procedures.
• Preparation, attendance, and follow-up of compliance inspections by national or international authorities, including implementation of actions.
• Contribute to the compilation of Periodic Quality Reviews and annual QA management reports.
• Active participation in discussions on the optimization of processes to efficiently improve the level of quality