Manager, Quality Control
vor 2 Wochen
**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.
**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.
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 winter break
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
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the fi
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