Senior Manager, Quality Operations
A leading biotechnology company that specialises in RNAi therapeutics is advertising a vacancy for an Senior Manager, Quality Operations position. The organisation uses this innovative form of therapy to treat rare genetic, cardio metabolic, acute hepatic infectious, central nervous system (CNS) and ocular diseases. The Senior Manager will join this company in their office in Amsterdam. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
- Performing pre-campaign readiness assessments to confirm completion of requirements prior to manufacturing.
- Providing oversight of the CMOs quality management system (QMS) to confirm adherence to the quality technical agreements.
- Providing effective oversight of manufacturing operations at the CMOs including on the floor support (at the drug substance CMO in Frankfurt, Germany) as needed. Actively observe manufacturing operations fordrug substanceon a routine basis to ensure compliance to cGMPs.
- Reviewing and approving CMO batch records, validation reports, test data package, deviations, and change controls.
- Evaluating and investigating manufacturing and lab deviations.
- Providing direction and recommendation as to future course of action.
- Interfacing with CMOs QA regarding any potential compliance gaps, significant/major deviation resolution, and regulatory inspections.
- Maintaining a risk-based ranking of outstanding compliance gaps and remediations tasks.
- Actively supporting the company's MRB Material Review Board and other forums for major investigations involving third party manufactured or tested company products.
- Preparing and presenting the information to senior management in support of the process.
- Managing required disposition activities needed for release of raw material, drug substance, drug product, and finished goods.
- Developing, negotiating, and maintaining the quality technical agreements per the established procedures to support manufacturing and testing.
- Working with CMOs to evaluate inspection readiness and ensure that appropriate corrective actions are taken to support expectations and successful inspection outcomes.
- Representing company Quality during any regulatory inspections of the CMOs.
- Providing strategic and tactical guidance as needed.
- Assisting with preparation of health authority audit observation responses.
- Participating in external audits of CMOs, ensuring compliance with all appropriate company and regulatory agency cGMP regulations and Policy.
- Developing and supporting authoring of the annual product quality review data summaries and sections in conjunction with the CMOs.
- Implementing and monitoring company vendor management key performance indicators at CMOs.
- Reporting on performance at CMOs for overall site metrics, key issues to be presented at the relevant quality review meeting.
Skills and Requirements:
- Minimum of 8 years of experience in pharmaceutical/biopharmaceutical drug substance operations, preferably with roles in both Manufacturing and Quality.
- Experience with batch record review and release.
- Strong experience with leading and managing quality investigations.
- Knowledge of Risk Management tools.
- Strong working knowledge of cGMPs requirements as applicable to drug substance.
- Experience in managing CMOs and driving process improvements.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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