ESO QA Manager

Job Description

MISSION STATEMENT The role of Quality Operation Manager is to manage team of QA specialists responsible for full quality lifecycle maintenance of dedicated product portfolio. Lead the QA specialists, define QA standards (way of working), identify and escalating gaps within the quality management system and proposing solution. Main Accountabilities And Duties Manage a team of QA Specialists responsible for the full quality lifecycle activities of dedicated product portfolio.Be the responsible quality representative and the main point of contact for quality related matter for subgroups (hubs) of subcontractors and third parties.Support and assure appropriate quality oversight into processes and over CMOs in scope of responsibility (hubs) to ensure product quality and compliance of activities performed at CMOs.To assure that activities connected to assigned hubs will be managed according to defined plans, processes and KPI.Supervision of selected processes such as (but not limited to): Management of deviation/non-conformities, complaints and related CAPAs managed in a compliant and timely manner Support preparation, participation and lead of escalations Compliance evaluation of Third Parties and products Edition, review and approval of QA agreements Management of CoA/CoC collection and review Review and issuance of PQRs / Stabilities data Training status of team members Definition of objectives Appropriate and timely reporting of KPIsSupport auditing activities: Prepare audits and audit plans Conduct, participate, lead external audits Evaluation of audit reports Participate to internal audits and inspections Creation of internal proceduresParticipate on project linked to the portfolio lifecycle management and optimizations. Supervise ordering of additional quality services at subcontractors and third parties as required and to assure correct invoice managementOther tasks may be performed under the direction of the Manager within the agreed type and scope of work. Required Qualifications, Experience & Skills University degree in Pharmacy, Chemistry, Biology, or relevant Life ScienceMinimum of 8 years in a similar role or equivalent experiences in a GMP related environmentMinimum of 2 years in a people management positionThorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirementsManagement of subcontractors is an advantageProven track record of project management skillsStrong communication skills and negotiation strengthSense of urgency, high autonomy & agile personalityProactive attitudeProblem solving skillsHands-on attitude, flexible and open mindedCollaborative and team-spiritedKnowledge of IT toolsLanguage - English: Advanced levelProblem solving skills