.The RoleJoining 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.Here's What You'll DoYour 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