Description
We are seaking a Senior Quality Manager consultant for QA support on dev projects to achieve development, submission and launch timelines, Audit- and Inspection QA support, QA DDS support on clinical activities, QMS medical device support
Tasks & Responsibilities
Role Purpose
Complex projects or late phase projects.
Manage global initiatives; manage complex projects (cross sites, high impact) independently.
Manage projects and processes to supportdepartmental portfolio, projects andobjectives according to agreed timelinesand standards.
Ensure that compliance with cGMP ismaintained in TRD.
Generic Activities
Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
Write, review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
Support Project management functions as a project team member.
Provide support to TRD line functions in GMP related topics as per area of responsibility.
Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
required tasks: We need an expert knowledge in medical device and combination product regulation (MDR, ISO 13485, FDA 820, FDA part 4)
Must Haves
Education /(minimum/desirable):
Bachelor (> 5 years’ pharma quality or operations)
Masters(> 3 years’ pharma quality or operations)
Languages:
Fluent English required (oral & written). Good skills in site (local) language desired (oral).
Experience/Professional requirement:
Good knowledge of cGMP, workingknowledge in technical development,production or QA.
Sound scientific, technical and regulatoryknowledge.
Strong organizational and decision-makingskills.
Strong and proven ability to analyze andevaluate cGMP compliance.
- Location:
- Duration