For one of our clients, a biotech company in full growth, we are looking for an experienced Quality Management Lead CMC. This mission is to cover for a maternity leave, starting as soon as possible.
The Quality Management Lead CMC is responsible for implementing the "pro-active quality principles" throughout the Chemistry, Manufacturing and Controls (CMC) organization by providing continuous support and input in the GMP area. The Quality Management Lead is the gatekeeper to ensure GMP compliance in the CMC organisation, e.g. ensuring that manufacturing, testing, IMP production and distribution processes are GMP compliant, relevant agreements are present and up to date, internal audits on critical CMC processes are executed and followed up, …. The Quality Management Lead is also involved in the management of Client CMC procedural documents (ProcDocs), i.e. in the creation, review, approval, distribution, revision and obsoleting Client GMP ProcDocs.
Provides continuous quality support by acting as an internal advisor on relevant Procedural Documents, processes and regulations to ensure correct interpretation and implementation to mitigate compliance risks.
Contributes and drives to create ProcDocs with CMC specific content.
Contributes to Procedural Document training content in the GMP area, in alliance with the Quality Management Training Lead.
Identifies areas for improvement based on Quality Management activities, audit findings and (updated) regulatory guidances.
Builds collaborative working relationships with cross-functional peers and relevant vendor representatives.
Builds a culture of compliance throughout the CMC organization.
Prepares and leads the monthly Quality meeting with the CMC management team, in collaboration with the Quality Assurance Specialist.
Collaborates to audit, assessment and inspection activities:
Leads/contributes to area specific Regulatory Authority Inspections.
Performs CMC supplier Quality Assessment visits, reporting and follow-up.
Collaborates with the Quality Assurance team in regards to audit and assessment programs.
Reviews audit reports and drives the proper CAPA formulation in alliance with the business stakeholders.
Leads/contributes to area specific internal audits.
Supports GMP activities and provides (project) quality oversight:
Identifies and addresses possible compliance issues during project team meetings in a pro-active manner.
Supports investigations (Product Quality Complaints, deviations, OOS,…) and escalates quality issues, if deemed necessary.
Owns and approves QP to QP agreements between Client and Qualified Person representatives of the GMP vendor.
Contributes and guides project specific Quality Risk Management activities.
Contributes to and approves Quality Agreements between Client and relevant GMP vendors.
Contributes to the Investigational Medicinal Product Dossier review rounds.
In -depth experience in development GMP
Ability to work independently
Fluent in English