The Role:\
Reporting to the Head Quality, International Organization, the Director of Quality Assurance Disposition will be responsible for providing QA oversight and support of Moderna\\xe2\\x80\\x99s international organization\\xe2\\x80\\x99s product disposition for clinical and commercial product manufactured at contract manufacturing organizations (CMO) and tested at contract laboratory organizations (CLO). This role will act as Qualified Person (QP) in accordance with EU GMP and manage other QPs to provide final certification/release along with ensuring overall maintenance of site quality management system (QMS) to support release of product for EU/EEA markets as well as wholesale distribution to EU countries. The Director of QA Disposition will ensure clinical and commercial drug substance and drug product as well as labeled and packaged product complies with cGMP, international regulatory requirements, and internal policies, procedures and specifications. This leadership role located in Basal, Switzerland will lead Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna\\xe2\\x80\\x99s international operations. The Director Quality Assurance Disposition will collaborate with Manufacturing, QC, QA Operations, QA Systems and Compliance, Regulatory Affairs and Supply Chain to ensure Moderna\\xe2\\x80\\x99s products are dispositioned on time to meet defined turnaround times to meet supply and customer requirements and manage Qualified Persons (QPs) to support release to EU countries. The incumbent will be an integral partner to Moderna\\xe2\\x80\\x99s innovative technology platform as we continue to integrate automation and digital technology into everything we do. \
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\Here\\xe2\\x80\\x99s What You\\xe2\\x80\\x99ll Do:\
Execute QP responsibilities, duties, batch certification and disposition for products in the EU as defined in EU Council Directives and Eudralex Volume 4, Annex 16. \
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Manage QPs and review and approve disposition documentation to certify compliance with cGMP and international regulatory requirements and internal policies, procedures and specifications. \
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Approve certificates of analysis and certificates of compliance in support of product disposition. \
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Manage overall disposition process to ensure on time disposition per approved and defined turn-around times to meet supply and customer requirements and timelines. \
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Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls). \
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Review batch records, testing records and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures. \
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Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria. \
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Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing operational activities and resolve equipment, testing, and process issues in support of product disposition activities. \
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Facilitate and coordinate disposition of product for applicable regions and markets with Regulatory Affairs (RA), Qualified Persons (QPs) and Supply Chain (SC). \
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Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management. \
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\Here\\xe2\\x80\\x99s What You\\xe2\\x80\\x99ll Bring to the Table:\
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years. \
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Minimum 3-5 years\\xe2\\x80\\x99 experience acting and executing Qualified Person responsibilities and duties as defined in EU directive 2001/83/EC (as amended). \
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Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participating in successful regulatory inspections. \
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Experience in product disposition processes and requirements and cGMP manufacturing and testing within biotechnology industry. \
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A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization. \
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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. \
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Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations. \
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Experience working with CMOs, CLOs, vendors, and relationship management preferred \
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Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment. \
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Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment. \
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A leader who is self-reflective and leads by example and drives the organization\\xe2\\x80\\x99s performance with an attitude of continuous improvement by being open to feedback and self-improvement. \
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Ability to navigate through ambiguity and rapid growth and adapt to change. \
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Track record of leading, coaching, and mentoring high-functioning and collaborative teams. \
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A \\xe2\\x80\\x98digital first\\xe2\\x80\\x99 and curious mindset that allows you to constantly learn and challenge the status quo. \
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Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. \
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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! \
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The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. \
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About Moderna \
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna\\\'s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. \
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Moderna\\\'s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com . \
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Moderna is a smoke-free, alcohol-free and drug-free work environment. \
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