Head of QA-PMI

 

Head of QA-PMI

Job Discription

Job Summary

Head of QA-PMI manages the department personnel and coordinates activities within the QA-PI, Microbiology and Quality Improvement departments that support R&D and Operations projects and issues. The expectation is that approximately 70% of time will be directly involved in R&D project activities and 30% department management.



Essential Duties/Responsibilities

· Management responsibility for the QA-PMI team in US, and related product families.

· Responsible for QA activities in R&D projects through integration into Global Operations in US.

· Responsible for the approval of new Quality Plans and derived QA instructions for Q-Site and/or production.

· Responsible for Sterilisation, Stability/Transportation requirements, and Microbiology – in coordination with QA-PMI team in Denmark.

· Ensure review of key R&D documentation such as Design Specification, Risk Management, Design Verification and Validation.

· Responsible for evaluation and approval of suppliers and contract manufacturers, including the specific QA relevant documentation (i.e. Technical Contract).

· Ensure the evaluation and approval of product changes related to new materials, new intermediates and new products.

· Participate in the establishment of final requirements for test methods, materials, intermediates and final products, and derived specifications.

· Review QA-PMI relevant part of the DHF/DMR documentation in order to ensure quality in the transferred production processes for products in US.

· Review and approve Process Validation protocols and reports from NPI.

· Ensure compliance to national/international quality standards in quality processes to be implemented in production.

· Team-responsible for the Design Transfer of new products from GRD to GO.

· Participate in Range Care Projects as appropriate (major changes requiring QA-PMI involvement).

· Manage the Launch Quality Surveillance Program for products in US.

· Decide on disposition and approval of activities related to CAPA assigned to QA-PMI for QA decisions.

· Act as the QA-PMI representative in any GRD/QBI coordination issues.

· Ensure relevant training of own team members, as well as others in US, within the QA-PMI activities – QA in R&D Projects, Sterilisation, Stability, Transport Testing, Microbiology – in coordination with QA-PMI team in Denmark.



Authorities and Limitations (non-exhaustive list)

· Authorised to carry out the duties and responsibilities above, including the release of products for sale, within Coloplast’s general rules and guidelines.

· Authorised to approve departmental expenditures within corporate policy.

· Cannot change policies or key global QA-PMI processes.

· Cannot change global strategy or activity plans.

· Cannot recruit or fire employees without prior involvement of superior (professional and people Manager).

· Cannot involve external persons in projects that may give them knowledge of strategic and tactical issues without previous acceptance from superior.



Job Requirements

· 4-year technical degree (e.g. engineering, biology, chemistry).

· 7 years industry experience, preferably with medical devices.

· Product development or innovation experience (preferred).