stillingsbetegnelse: QC Director

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! At CMC Biologics A/S, we work with the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing. Since we are a contract manufacturing organization, a high level of service to our clients is in focus. The department The new QC Director will report to the Vice President of Quality. The QC laboratory consists of 30+ employees organized in 3 departments, QC Bioassay, QC Chemistry and QC Microbiology. Each department is headed by a Manager. Besides daily lead of direct reports and general management of QC activities, the QC Director will participate in strategic initiatives and customer meetings. Aim is to help identifying the analytical packages needed for the projects in close collaboration with CMC Biologics Process Development groups. The QC Director will work closely with the members of the CMC Biologics Leadership Team and provide both strategic and day-to-day guidance to the Business Development Team and Project Management Team. The QC Director will have a leading role during FDA and EMA Inspection’s and during customer audits. Main purpose of the position: • Direct staff and operations within Quality Control in accordance with cGMP regulations and CMC Biologics standards. • Establish strategic goals and objectives and maintain full strategic responsibility for Quality Control. • Provide leadership and guidance to immediate staff performing Quality Control activities. • Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment. • Provide leadership and take a leading role during FDA and EMA Inspection’s and during customer audits Job Duties/Responsibilities: • Manage and administer all aspects of people processes related to the employee lifecycle. • This includes the selection, hiring and training of personnel on company and department policies, systems and processes. • Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. • Manage and ensure the setting of realistic personal goals for staff and provide regularly scheduled feedback throughout the year. • Ensure staff receives appropriate knowledge and skill development and growth opportunities. Direct staff to: • Set business goals for their groups. • Establish and monitor performance measures and objectives for their groups. • Optimize resources, processes and systems. • Approve and oversee improvements to Quality operational policies, plans and procedures. • Provide input to and rationale for department budget. • Monitor and control expenditures against department budget. • Provide input for the development of overall Quality objectives and long-range goals. • Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. • Direct and participate in continuous improvement initiatives for CMC Biologics Quality Systems. • Sign documents for activities as authorized and described by CMC Biologics policies, procedures and job descriptions. • Support and ensure staff follows proper safety precautions and laboratory technique in the use of reagents and other chemical compounds. • Perform any other tasks as requested by Senior Management to support Quality oversight activities. Technical Duties/Responsibilities: • Establish robust Quality Control management and testing processes. • Ensure data is documented, and reported following cGMP procedures. • Ensure that the QC Department is ready for Pre-Approval Inspections and DHMA Inspections. • Direct the review and approval of the following documents and provide guidance as needed: • QC SOPs • Across disciplines • Proposed in-process test procedure changes • CMC regulat

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark