Manager, External Quality Control

**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 and Asia - 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.

**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 an