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 KPIs
Support 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 procedures
Participate 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 management
Other 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 Science
Minimum of 8 years in a similar role or equivalent experiences in a GMP related environment
Minimum of 2 years in a people management position
Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
Management of subcontractors is an advantage
Proven track record of project management skills
Strong communication skills and negotiation strength
Sense of urgency, high autonomy & agile personality
Proactive attitude
Problem solving skills
Hands-on attitude, flexible and open minded
Collaborative and team-spirited
Knowledge of IT tools
Language - English: Advanced level
Problem solving skills
