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  • To be considered for this role, you must supply a CV / resume in English (as English is our internal business language)

Additionally, this role will be working closely with our CMO partners who have locations in Europe (Italy) - therefore, trips to the sites are expected to be frequent (as we have a face-to-face / on-site ethos)**

The Role:

Reporting to the Sr. Manager of External Quality Control (QC), the Manager External QC will be responsible to manage the External QC testing for outsourced late phase clinical and commercial manufacturing. They will be responsible for overseeing QC activities at contract manufacturing and testing facilities to ensure compliance with internal policies, procedures, and regulatory requirements.

As Manager of External QC, you will provide support for design, execution, troubleshooting and monitoring of QC processes and testing activities at contract manufacturing organizations (CMOs) (including raw material, stability, in-process, and release testing) and oversight of Contract Testing Laboratories (CTLs) to ensure compliance and business needs are met. The incumbent will lead or represent QC for improvement initiatives, ensuring 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 CTLs for QC operations processes and lead all related analytical topics with the expertise to address directly or through appropriate collaboration within the company network.
  • Will be in close connection with Global QC team, for contribution to global process improvements and communications (escalation/cascade) as appropriate
  • Lead critical investigations related to Quality Control (methods, equipment, results, samples, analytical method lifecycle, audits, and inspections) in collaboration with internal and external QC operations and partners.
  • Centralize planning of External QC activities with all CMOs to ensure timely execution of planned activities, notification/escalation, and resolution of issues.
  • Ensure purchase requisitions and purchase orders are managed as appropriate to ensure business needs are met in timely manner.
  • Support External QC as necessary for the review and approval of relevant cGMP documentation including policies/SOPs/reports/protocols/ specifications.
  • Support External QC for laboratory investigations and 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 subject matter experts in Quality Control (QC), Analytical, Science & Technology (AS&T), Manufacturing Science and Technology (MS&T), Quality Assurance (QA), QA Disposition, Supply Chain (SC) to support ongoing operational activities, resolve issues related to QC testing and continuous improvement and performance of QC operations.

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

  • Bachelor’s degree in relevant scientific discipline (life science, chemistry) with minimum of 6- 8 years’ experience in quality control applied to Commercial/Global cGMP Biotech or Pharma
  • Working knowledge of relevant US, 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 the status quo.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

  • Quality healthcare and insurance benefits
  • Lifestyle Spending Accounts to create your own pathway to well-being
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Family planning and adoption benefits
  • Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
  • Educational resources
  • Savings and investments
  • Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) 

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