Manager, Quality Control

Manager, Quality Control

Moderna

Basel, Switzerland

The Role:

Reporting to the Director of External QC for the International Organization, the Manager External QC will be responsible for supporting QC activities at contract manufacturing and testing facilities to ensure compliance with internal policies, procedures, and regulatory requirements.

The Manager External QC will provide support for testing activities including stability, raw material, in-process and release testing at contract manufacturing organizations (CMOs) for drug substance and drug product fill finish activities and oversight of Contract Testing Laboratories (CTLs) to ensure compliance and business needs are met. The incumbent will manage QC improvement initiatives to ensure robust quality control processes are implemented across Moderna’s international operations and 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:

  • Act as QC single point of contact for designated CMOs and CTLs and manage all analytical deliverables with the expertise to address directly or through collaboration with appropriate experts within the company network (Analytical, Science & Technology, Global QC);
  • Bring your QC expertise and proactive mindset to identify and execute improvement initiatives to ensure the external QC team can effectively meet all stakeholder demands;
  • Lead complex laboratory investigations to resolution with external partners, CMOs, CTLs, National Testing Laboratories and manage internal escalations appropriately with cross-functional teams;
  • Provide oversight of end-to-end QC activities at external partners for new product introduction and implementation of significant analytical changes;
  • Lead QC oversight of analytical method transfer projects at CMOs and CTLs and provide expert analytical input into the quality control strategy for commercial product;
  • Provide QC support for the review and approval of all cGMP documentation including policies/SOPs, analytical data, analytical test methods, analytical method transfer and validation protocols/reports, stability protocols/reports, specifications;
  • Provide QC support for timely completion of all quality system records related to testing activities; OOS/OOT, Deviation, CAPA, and Change Controls;
  • Collaborate with Regulatory CMC, providing expert analytical input to relevant sections of the dossier to ensure submission timelines and regulatory commitments are met;
  • Collaborate with manufacturing and contract testing facility personnel and internal subject matter experts in Analytical, Science & Technology, Manufacturing, Science & Technology, QA Operations, QA Release and Supply Chain Planning to support ongoing operational activities and resolve issues related to QC testing.

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

  • Bachelor’s degree in relevant scientific discipline with minimum experience of 8-10 years within quality control;
  • 2-3 years management/supervisory experience in cGMP organization;
  • Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections;
  • Experienced in executing quality control testing, analytical method transfers and validation within a biotechnology industry;
  • Fluency (written/spoken) in English – fluency in other languages is advantageous;
  • A proven track record of success in managing analytical projects with external testing sites in a biopharma organization;
  • 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, CTLs, 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

Switzerland     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Moderna    

© EuroJobsites 2022

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 2022

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