Manager, Quality Assurance Operations

Manager, Quality Assurance Operations

Moderna

Geleen, Netherlands

The Role:

Reporting to the Senior Manager, Quality Assurance Operations Drug Substance - Team Lead for the International Organization, the Manager QA Operations will be responsible for providing QA oversight and support for contract manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements.

The Manager QA will support Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international operations. The incumbent will provide person in plant QA presence at contract manufacturing organization (CMO) site in the area of Geleen, Netherlands for oversight of drug substance and testing activities and support review and approval of all cGMP documentation including policies/SOPs, testing data, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPA, and Change Controls. The incumbent will be an integral partner to Moderna’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.

Here’s What You’ll Do:

  • Provide person in plant QA presence at contract manufacturing organization (CMO) site the Netherlands to adherence to approved policies, SOPS, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation and resolution of any issues and nonconformities.
  • Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).
  • Support quality investigations and manage CAPA (corrective and preventative actions) for CMO activities.
  • Review and coordinate approval of all changes made to the manufacturing, testing and control processes including those that are initiated by CMOs and Contract Laboratory Organizations (CLOs).
  • Review batch records, testing records and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures.
  • Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria.
  • Provide QA oversight at contract manufacturing sites to ensure compliance with approved quality agreements and overall cGMP compliance for Moderna’s drug substance and drug products.
  • Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing operational activities and resolve equipment, testing, and process issues.
  • This role requires approximately 40% international travel.

Here’s What You’ll Bring to the Table:

  • Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 5-8 years.
  • Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections.
  • Experience in computerized systems, automation, operations and manufacturing and testing within biotechnology industry.
  • A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization.
  • Fluency in English and Dutch (spoken and written), German would be an advantage
  • Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
  • Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
  • Experience working with CMOs, CLOs, vendors, and relationship management preferred
  • Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.
  • Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
  • Ability to navigate through ambiguity and rapid growth and adapt to change.
  • A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Netherlands     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Moderna    

© EuroJobsites 2021

EuroJobsites is a 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

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a 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

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies