Senior Manager, Quality Assurance CMO

Senior Manager, Quality Assurance CMO

Alnylam Pharmaceuticals

Amsterdam, Netherlands

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.

In addition, the candidate will be required to provide occasional support to other Alnylam CMOs in Germany and Switzerland that provide raw materials, drug product and finished goods.

This position will be principally located in Amsterdam, Netherlands with frequent travel to the drug substance CMO in Frankfurt, Germany. This position reports to the Associate Director, QA in Zug, Switzerland.

Summary of Key Responsibilities

  • 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 Alnylam MRB Material Review Board and other forums for major investigations involving third party manufactured or tested Alnylam 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 Alnylam expectations and successful inspection outcomes;
  • Represent Alnylam 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 Alnylam 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 Alnylam 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.

Qualifications

  • Demonstrated 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;
  • Strong leadership and negotiation skills;
  • Must have excellent verbal, written and interpersonal communication skills;
  • Ability to travel approximately 50% of the time.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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