Quality Manager - External Manufacturing

Location
Cork
Salary
Competitive
Posted
08 February 2017
Closes
08 March 2017
Ref
CW120011
Position / level
Manager
Contract Type
Permanent
Hours
Full Time

A Quality Manager - External Manufacturing is required by CareerWise Recruitment for our Cork based biotech client. 

ROLE OF THIS POSITION

  • You will be responsible to implement Quality Operations (Quality Assurance and Quality Control) policy and discharge all QO responsibilities supporting external parties/partners and alliances (EP’s) for manufacture, testing, packaging, storage, and distribution of pharmaceutical products,
  • These activities include assuring that products are produced from approved processes in conformance to all applicable regulatory requirements and Company policies and may include the release of all manufactured products.
  • The incumbent will exercise a leadership role in monitoring and maintaining the EP’s compliance with the FDC Act, current Good Manufacturing Practices Regulations (domestic and foreign), and other pertinent legal requirements.
  • You will ensure the quality performance of EP’s through direct oversight, support and technical advice, counselling to the EP site senior leadership and providing on-site supervision as appropriate.
  • You will oversee activities such as EP selection, GMP Due Diligence, and establishing Quality Agreements. The incumbent also provides support to build effective quality systems and drive continuous improvement activities at the EP.
  • You will participate in end to end risk management and strategic initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce within the extended external manufacturing organization.
  • This role will involve about 15% travel

 

JOB REQUIREMENTS

  • B.Sc. in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
  • Minimum of 7 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.
  • Competent in analyzing complex product, production and testing issues and have demonstrated scientific problem solving capabilities.
  • Possess strong compliance mindset, demonstrated interpersonal skills, including leadership and coaching, motivation, communication and negotiation.
  • Some level of contractual and financial awareness is required


For further information please contact Brian Flynn (Executive Search) for more information or to apply - click APPLY.

Apply for Quality Manager - External Manufacturing

Already uploaded your CV? Sign in to apply instantly

All answers are required

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left


By applying for a job listed on Executive Jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.