Associate / Director, External Quality Control

ModernaTX, Inc. (Basel, Schweiz) Vor 4 Tagen veröffentlicht

The Role:
Moderna is seeking an AD/D External Quality Control based in Basal, Switzerland to oversee Quality Control (QC) testing including in-process, release, and stability in support of contract manufacturing and testing facilities and overall international operations for Moderna clinical and commercial products.  This position reports to the Head Quality, International Organization and will develop and implement QC methods, systems, policies, procedures and controls as they relate to QC testing of raw materials, drug substances and drug products and manage method lifecycle projects, coordinating across teams to meet business objectives.

Here’s What You’ll Do:

  • Establish testing program requirements at contract manufacturing and contract laboratory organizations for raw materials, drug substance and drug products and oversee overall day to day testing operations.
  • Manage in-process, release and stability testing, data trending, analysis and reporting to support timely release of product and ensure compliance to approved specifications.
  • Review executed QC test records for product release, including the investigation and resolution of deviations, Out of Specifications (OOS) and Out of Trends (OOT) observations.
  • Oversee and execute method transfers and method validation projects with contract manufacturing and contract testing laboratory organizations.
  • Author method acquisition and validation protocols and reports and author QC CMC sections for regulatory filings.
  • Monitor and communicate method lifecycle (acquisition, validation, implementation) timelines using project management tools.
  • Oversee and provide technical assessments for QC investigations, change control, and CAPA and resolve issues related to assay failures, system deficiencies, deviations, and equipment / assay troubleshooting.
  • Responsible for creating/revising and review/approval of QC policies, procedures, protocols and reports.
  • Lead continuous improvements of systems (procedures and systems) to improve organization effectiveness and ensure compliance. Support preparation, management and response to compliance audits. 
  • Assist in Quality Metric review processes, assess data for adverse trends, develop solutions and oversee implementation.
  • Participate in and partner with the Digital team to expand and optimize the use of the LIMS system.   
  • Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management.
  • This role requires approximately 25% international travel.

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

  • Bachelor degree in relevant scientific discipline with applied cGMP laboratory setting industry experience of 10-15 years.
  • Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
  • Knowledge with QC operations including bioassay, chemistry, and microbiology and HPLC Instrumentation/ Software experience
  • Proven skills in technical writing for method validation documentation, QC trending reports, technical assessments for investigations and change controls and CMC sections of regulatory filings.
  • Working knowledge of relevant EU and global regulations and ICH standards/guidelines and experience in participating in successful regulatory inspections.
  • Experience in general laboratory operations, method acquisition, method validation, computerized systems, and manufacturing and testing within biotechnology industry.
  • 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.
  • 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.
  • A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement.
  • Ability to navigate through ambiguity and rapid growth and adapt to change.
  • Track record of leading, coaching, and mentoring high-functioning and collaborative teams.
  • A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

About Moderna:

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit [...] Mission:

Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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Associate / Director, External Quality Control

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