Senior Manager, Quality Operations
A leading biotechnology company that specialises in RNAi therapeutics is advertising a vacancy for a 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.
This position's primary role is to provide on-site (person in plant) Quality Operations and compliance management for a drug substance contract manufacturing organization (CMO) located in Frankfurt, Germany. Responsibilities include managing manufacturing and disposition activities as well as deviations, CAPA, and change controls. The successful candidate will ensure the CMO meets internal Alnylam and health authority expectations regarding the cGMP manufacturing. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals.
- Perform pre-campaign readiness assessments to confirm completion of requirements prior to manufacturing.
- Provide oversight of the CMOs quality management system (QMS) to confirm adherence to the quality technical agreements.
- Provide 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 for drug substance on a routine basis to ensure compliance to cGMPs.
- Review and approve CMO batch records, validation reports, test data package, deviations, and change controls.
- Evaluate and investigate manufacturing and lab deviations. Provide direction and recommendation as to future course of action.
- Interface with CMO's QA regarding any potential compliance gaps, significant/major deviation resolution and regulatory inspections. Maintain a risk-based ranking of outstanding compliance gaps and remediations tasks.
- Actively support the company's MRB Material Review Board and other forums for major investigations involving third party manufactured or tested company products. Prepare and present the information to senior management in support of the process.
- Manage required disposition activities needed for release of raw material, drug substance, drug product and finished goods.
- Develop, negotiate, and maintain the quality technical agreements per the established procedures to support manufacturing and testing.
- Work with CMOs to evaluate inspection readiness and ensure that appropriate corrective actions are taken to support company expectations and successful inspection outcomes.
- Represent company Quality during any regulatory inspections of the CMOs. Provide strategic and tactical guidance as needed.
- Assist with preparation of health authority audit observation responses. Participate in external audits of CMOs ensuring compliance with all appropriate company and regulatory agency cGMP regulations and Policy
- Develop and support authoring of the annual product quality review data summaries and sections in conjunction with the CMOs.
- Implement and monitor company vendor management key performance indicators at CMOs.
- Report 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.
- Strong auditing experience.
- 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 Steven Fuller at +44 203 854 0674 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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