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Supplier Quality Assurance, Manager - Pharmaceuticals

Brunswick, ME, US Norcross, US

Ref. number:  3257

Are you passionate about making life better for patients worldwide?

 If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home. We’re looking for people who want to improve outcomes for healthcare professionals and their patients. 

 

We are currently searching for a Supplier Quality Assurance Manager in the US. Ideally based near our Maine, SC or GA faciliites, we will consider remote employees!

 

The role: 

This role will give you the chance to lead the USA & EMEA supplier quality assurance activities for the pharmaceutical and antiseptic product manufacturers, including oversight of GMP compliance and other relevant regulations. You will ensure that the suppliers are evaluated and approved in relation to quality, environmental and ethical standards.

 

Key Accountabilities: 

  • Act as the supplier approval owner for the global antiseptics supply chain (CMO’s, Suppliers etc)
  • Manage all operational quality aspects related to the supply chain
  • Maintaining Quality Agreements in line with GMP
  • Lead and participate in continuous improvement projects
  • Oversee CAPAs, FMEA and other failure investigation activities
  • Support in the development and improvement of material specifications
  • Perform internal and supplier audits, acting as lead auditor
  • Monitor suppliers manufacturing capability in order to improve quality and competitiveness
  • Lead and support in supplier risk activities and quality complaints meetings
  • Support suppliers in the relation to materials and components quality
  • Ensure that site distribution authorisation is maintained in accordance with GDP
  • Plan and implement objectives and actions in line with company strategies and plans

 

Qualifications & Experience:

  • Bachelor's in Science or related discipline
  • Significant experience of working within the pharmaceutical supplier quality area
  • Trained internal and Lead Auditor
  • Good Manufacturing Practice and FDA Pharmaceutical Regulations; Good Distribution Practice (specifically Pharmaceutical)
  • ICH Quality Guidelines
  • 3rd Party Contract Manufacturing
  • Previous management of 3rd party contract manufacturers
  • Ability to travel to Europe and USA
  • Employees hired after November 1, 2021 are required to be fully vaccinated within 30 days of their employment as a requirement of employment.  During the first 30 days, if not already fully vaccinated, employees will be required to test weekly at their own expense. 

 

 

About Mölnlycke  

Mölnlycke is a world-leading medical solutions company. We design and supply medical solutions to enhance performance at every point of care – from the hospital to the home.   

We specialize in:   

  • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®  
  • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients  
  • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves  

 


Nearest Major Market: Portland Maine