QC Manager

Hobson Prior are in search for a QC Manager to join a fantastic pharmaceutical organisation on a contract basis located in Zurich with remote-working available to those already located in Switzerland. Our client is focused on the translation of science into highly innovated medicines.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• The ideal candidate will be responsible for directly liaising with, and manages, relationships with external testing partners to ensure continuity of testing, investigation and resolution of unexpected results and represents the company in interactions with providers.
• Develops, compiles and monitors performance metrics and drives continuous improvement of activities within QC organization.
• You will lead or support analytical and manufacturing investigations of unexpected results to identify root cause and defines and implements corrective or preventive actions.
• Works closely with OncESSM Quality OpU leadership to support the forecast of future spend, monitoring variances, and drive improvements with financial benefit.
• Responsible for operational, technical and compliance oversight for Global Oncology External Supply Small Molecule (OncESSM) Quality Operating Unit (OpU) Quality Control (QC) release and stability testing performed at external service provider (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule, recombinant biologics and cell therapy products as part of the global QC function.
• The candidate will be responsible for creating, maintaining analytical documentations, e.g. protocols, reports, specifications, methods, etc.
• Provides support to data analysis, data entry, purchase order creation/reconciliation and financial oversight of third-party labs in Europe and other regions as required by the third-party lab locations.
• Supports compliance of testing network through participation in external provider audits, data review and data integrity verification, development of quality agreements and assures execution to requirements.
• Support regulatory filing and product APQR.
• Any other assigned duties.

Key Skills:

• Communication - strong verbal and written communication skills with the ability to communicate ideas and data in a persuasive, organized, and appropriate manner.
• Analytical Skills - ability to thoughtfully analyse a wide variety of information and data to make key decisions.
• Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management.
• Proactiveness - ability to anticipate potential problems and taking the initiative to address these issues.
• Regulatory Understanding - general knowledge of regulations associated with manufacturing and packaging.
• Customer Service Orientation - ability to gain trust of leadership and leverage relationships to provide best possible financial plans.
• Fluent in written and spoken English.

Requirements:

• MS or PhD in Chemistry, Biology, or related scientific discipline.
• 7+ years experience in in the pharmaceutical industry and QC laboratory environment is a must.
• Must have in-depth and hands on experience of analytical techniques such as Mass.
• Spectrometry, NMR, HPLC, dissolution, GC, FTIR, wet chemistry and other analytical techniques.
• Must have broad experience in analytical investigations, handling of OOS, OOT investigations.
• Experience in small molecule API and oral solid dosage is a must.
• Experience in analytical laboratory, method execution, qualification and/or validation of small molecule or biologics assays.
• Experience in managing stability programs.
• Experience in regulatory support, authoring dossier sections, respond to regulatory inquires.
• Cross functional and matrix management experience.
• Awareness of financial processes.
• Project management experience is a plus.
• In depth understanding of applicable regulations and guidance's.
• Strong proficiency in Microsoft tools, especially Excel.
• Knowledge of Laboratory Information Systems (LIMs).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.