Associate Qualified Person

We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.

You will serve as a quality consultant to designated operational group(s) and will be responsible for:

• Identification of process improvement opportunities.
• Process authoring and review, support for process re-engineering
• Provide GxP and process expertise to designated operational group(s)
• Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned

Key responsibilities also include that:

• Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.
• Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.
• Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).
• Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.
• Batch certification is recorded in a register or equivalent document.
• Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.
• Delegation of any QP-tasks is performed only to another Qualified Person(s).
• Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.
• Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.
• A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.
• A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.
• Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).
• Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.
• Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.

Skills, Knowledge and Experience

• Excellent knowledge about EU and global GMP, GCP and GDP regulations
• Experience with EU QP-Batch Certification and Release procedure of IMP
• Excellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)
• Experience with Import & Export of pharmaceutical products
• Experience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement required
• GMP / GDP auditing experience
• Authority Inspection experience
• Project management and leadership abilities: Six Sigma LEAN Green Belt or above
• Experience in Quality Control and Quality Assurance required
• Ability to think and work globally and be culturally aware
• Ability to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business Units
• Ability to act as the main quality interface with clients
• Customer-focused in defining and establishing priorities
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
• Highly IT literate: Microsoft based applications
• Ability to travel as needed for the position

Language Skills

• Must have fluent speaking, written & verbal skills in German and English

Education

• Fulfilment of qualification as per *15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):
• Registered Pharmacist in Germany
• Practical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal products
• PhD degree preferred