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Manager, Quality Assurance for Quality Control
hace 2 semanas
**The Role**
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is solidifying its footprint in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.
In this role, you will provide quality oversight and guidance to Quality Control (QC) and Analytical Science and Technology (AST) across Moderna's global network. This individual is a key member of the Quality Assurance for Quality Control team, building a culture of quality in our GxP and GMP laboratories. The Manager of QA for QC supports global laboratories, including those in Norwood, Madrid, Resilience sites, and external testing labs.
**Here’s What You’ll Do**
**Your key responsibilities will be**:
- Ensure the quality policy and objectives are understood, implemented, and maintained at all levels within the QC and AST laboratories.
- Ensure QC and AST quality systems, processes, specifications, methods, and SOPs are appropriately designed and compliant with global pharmacopoeia and regulatory requirements.
- Author, review, and approve QC/AST SOPs, reports, policies, Annual Product Quality Reviews (APQR), and trend reports to ensure cGMP compliance.
- Provide oversight during technical development phases to ensure activities comply with internal quality standards.
- Evaluate and monitor the integration of quality assurance in QC and AST processes, ensuring alignment with program phases.
- Identify risks and gaps in quality and GMP process/systems and communicate them effectively.
**Your responsibilities will also include**:
- Review and approve deviations, change controls, work orders, laboratory investigations, SOPs, and commissioning/qualification documents for QC equipment.
- Ensure personnel follow Good Documentation Practices and Data Integrity requirements.
- Support audits and inspections with compliant and accurate data, documentation, and records.
- Review and approve facility alarms and facility work order requests.
- Additional duties as may be assigned from time to time.
**The key Moderna Mindsets you’ll need to succeed in the role**:
- **We behave like owners**:In this role, you will have ownership of quality systems and processes, ensuring that they exceed compliance standards and meet Moderna's strategic objectives.
- **We push past possible**:Your innovative mindset and commitment to high standards will help drive the continuous improvement of QC and AST systems, supporting the global mission of delivering groundbreaking mRNA medicines.
**Here’s What You’ll Need (**Basic**Qualifications)**
- **Education**:Bachelor’s Degree in Biology, Microbiology, Chemistry, Biochemistry, or related field.
- **Experience**:5-8 years of experience in the pharmaceutical/biotech industry within Quality Assurance or Quality Control.
- **Specific Certifications or Training**:None
**Here’s What You’ll Bring to the Table (Preferred Qualifications)**
- Management/supervisory experience in a cGMP organization.
- Experience in analytical or microbiological method validation and/or medical device QA.
- Familiarity with environmental monitoring, microbiological testing, or chemistry analytical techniques.
- Knowledge of FDA, EU, ICH guidelines, and relevant regulations.
- Proficiency in Microsoft Office tools and statistical programs/software.
- Experience with risk management and digital solutions for quality systems.
- A desire to make an impact as part of a high-growth, transformational company that is **Bold, Relentless, Curious, and Collaborative.**
- This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.
**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, a
