Regional Manager of Quality
Regional Manager of Quality
Phillips-Medisize, LLC is seeking a Regional Manager of Quality based in Sligo or Letterkenny, Ireland (any other location in Europe could increase travel). This position will ensure the effective maintenance of manufacturing quality and representing the business related to the Food and Drug Administration (FDA), European Commission (EC) other country specific regulated governing bodies.
- Provide direction and leadership to the Quality department leadership at sites, including people management
- Devise and implement quality systems/procedures that provide continual improvement methodology supporting manufacturing and operational consistency
- Evaluate new and changing federal, state and local regulations that impact medical device, drug operations and regulated products and communicate changes throughout the organization to minimize regulatory risk
- Work with Sales and Marketing, Program and Project Management to ensure that regulatory requirements are appropriately considered and accounted for in new programs and projects for sites and new combination products
- Identify and develop resources required to support customers’ product-specific needs and requirements
- Assist regional director in deploying projects/programs successfully across the region and ensuring that correct resources and skills are available at site
- Ensure compliance with applicable European and Divisional quality system requirements and assist with development of quality system elements required to support new technologies and processes
- Interface with manufacturing, engineering, customer service and other functional areas
- Support external customer audits
- Work with management to establish quality goals and objectives
- Assist in deploying the divisional QMS and ensuring it is successfully implemented at sites
- S. degree in quality, science, business, engineering field or another technical field
- 8+ years of experience in a quality role, with 5+ of those years in a management role
- Experience establishing quality systems and procedures related to emerging regulations
- Experience in regulated discipline/industry
- Thorough knowledge of FDA and EU international regulations and ISO standards related to manufacturing (e.g. CFR 210/211/820, EU MDR, EU MHRA, ISO 9001, ISO 13485, ISO 14971, NMPA)
- Direct experience with audits and pre-approval inspections by regulatory authorities
- Direct experience of working in a pharmaceutical and/or combination product manufacturing environment required
- Experience of working on NPI teams and managing people involved in NPI projects
- Thorough knowledge of current good manufacturing practice (cGMP)
- Thorough knowledge of quality tools, such as root cause analysis
Skills and Abilities:
- Strong written, verbal and interpersonal communication skills
- Demonstrated team leading, problem solving and project management skills
- Ability to work with all levels within the organization, as well as customers and vendors
- Decision making and prioritization skills
- Ability to travel 50% globally
With your application, you agree that your information will be recorded in our files (up to 6 months after finalizing the position) and if necessary, forwarded to affiliated companies.
We are an equal opportunity employer.
The Company – in short
Phillips-Medisize, LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.
Read more about Phillips-Medisize A/S at www.phillipsmedisize.com or follow us at LinkedIn.
To apply for this job please visit sjobs.brassring.com.