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Job Details

**Associate Director Quality Management, Qualified Person (QP) - Munich!**

Company: Advanced Clinical Recruitment Ltd
Location: Munich
Reference: QA-AD-QP
Closing Date: 14 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary + Package

Job Summary:

A very interesting and exciting Global Biopharmaceutical company is actively looking for an Associate Director Quality Management and QP to join their expanding team based in Munich! The company are originally a US company, but they are now growing within Europe and are making two European locations hubs for the company, one specifically being Munich! The role will require a QP (permanent provisions and an experienced Quality professional who is eager to grow with the team!

Requirements:

The Associate Director Quality Management will act as a Qualified Person in accordance with EU GMP to provide final certification/release of clinical and commercial pharmaceutical products along with Quality Assurance and Regulatory support. While based at our Germany office the role will also include Responsible Person responsibilities for the Quality oversight of commercial product distribution in Germany. The Associate Director Quality Management is a member of the International Quality Assurance team and will manage the International GMP/GDP compliance program.

 

Key Responsibilities

EU/EEA Qualified Person responsibilities include:

  • Day to day batch release and certification of commercial product in the EU to ensure the batch and its manufacture comply with the GMP and provisions of the marketing authorizations
  • Day to day batch release and certification of IMP destined to European clinical trials to ensure the batch and its manufacture comply with the GMP, product specification file and clinical trial applications
  • Maintenance of a Batch Register
  • Providing QP GMP declarations in support of importation and regulatory activities
  • Ensuring that the principal manufacturing and testing processes have been validated
  • QP review and evaluation of deviation, complaints, change controls, PQRs
  • Performing QP audits
  • Establishing QP to QP agreements when required
  • Be continuously contactable

 

Germany Qualified Person/Responsible Person Responsibilities Include:

  • Establishment and maintenance of the QMS and ensure a state of inspection readiness
  • Batch release to the German market
  • German distribution quality oversight
  • Performing self-inspection and ensuring GMP and GDP compliance at the Germany site
  • Interact with the local Bavarian Authorities as it pertains to the Licenses and GMP/GDP activities

 

International Compliance Program Responsibilities Include:

  • Develop and manage the International GMP/GDP vendor audit program
  • Develop and manage the International GMP/GDP Internal audit program
  • Verify that all audits have been carried out as required by the quality assurance system, and extend support to team when required.
  • Maintain knowledge of current guidelines and GMPs in line with duty for continual professional development and to establish a regulatory compliance watch
  • Provide expert review of CMC submissions

 

Interface:

  • Supply Chain
  • CMO QPs
  • CMO
  • RA-CMC

 

Requirements

  • The candidate must be fully qualified QP with experience of final certification/release within the EU/EEA. Quality systems management, audit experience (internal and external) and a strong EU regulatory understanding are also essential for this role.
  • A good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and importation would be advantageous.
  • The ideal person will have the experience and the confidence to interact with QA and Regulatory teams and will have the strength of character to guide teams of professionals. Small molecule and biotech large molecule QP experience would be a distinct advantage but applications from QPs that have had exposure to a broad range of activities are welcome.
  • Graduate, preferably in Chemistry, Pharmacy or Biological Science.
  • Wide ranging technical knowledge and experience within the pharmaceutical industry.
  • Substantial previous Quality Assurance experience
  • Excellent scientific and technical knowledge
  • Is multi-skilled across a number of areas and has developed specialist expertise relevant to function.
  • Up to date knowledge of cGMP, cGDP and regulatory expectations
  • Team player and ability to work with remote teams
  • Travel up to 30%
  • English fluency written and spoken (the company language)
  • Strong verbal and written communication skills with well-structured communication and presentation ability
  • Strong interpersonal skills

 

For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!

 

Sam Caley - Advanced Clinical Recruitment

+44 (0) 114 294 5008

scaley@acr-uk.com 

LinkedIn Search: Sam Caley Quality Assurance

 

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Apply for this job: **Associate Director Quality Management, Qualified Person (QP) - Munich!**

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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