Manager External QC

Job content

The Role

Reporting to the Director of External QC for the International Organization, the Manager External QC will be responsible for supporting QC activities including the lead of analytical method transfer projects 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, in-process and release testing at contract manufacturing organizations (CMOs) for drug substance and drug product fill finish activities and oversight of Contract Laboratory Organizations (CLOs) 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 single point of contact for designated CMOs and CLOs and manage all analytical related topics with the expertise to address directly or through collaboration with appropriate experts within the company network.

• Lead analytical method transfer projects at CMOs and CLOs and provide expert analytical input into the quality control strategy for commercial product.
• Lead laboratory investigations and troubleshooting of methods and equipment to support QC operations at external testing sites and ensure timely notification/escalation and resolution of issues.
• 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 laboratory investigations and quality system records related to testing activities; OOS/OOT, Deviation, CAPA, and Change Controls.
• Manage method lifecycle projects coordinating across internal and external teams to ensure business needs are met.
• 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 testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Assurance (QA), QA Disposition, Supply Chain (SC) 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, 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.
  

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

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