Director, Quality Assurance - Release

Director, Quality Assurance - Release

Moderna

Basel, Switzerland

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’s international organization’s 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’s 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’s 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’s innovative technology platform as we continue to integrate automation and digital technology into everything we do.

Here’s What You’ll 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;
• Manage QPs and review and approve disposition documentation to certify compliance with cGMP and international regulatory requirements and internal policies, procedures and specifications;
• Approve certificates of analysis and certificates of compliance in support of product disposition;
• Manage overall disposition process to ensure on time disposition per approved and defined turn-around times to meet supply and customer requirements and timelines;
• Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls);
• 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;
• Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria;
• 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;
• Facilitate and coordinate disposition of product for applicable regions and markets with Regulatory Affairs (RA), Qualified Persons (QPs) and Supply Chain (SC);
• Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management.

Here’s What You’ll Bring to the Table:

• Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10-15 years;
• Minimum 3-5 years’ experience acting and executing Qualified Person responsibilities and duties as defined in EU directive 2001/83/EC (as amended);
• Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participating in successful regulatory inspections;
• Experience in product disposition processes and requirements and cGMP manufacturing and testing within biotechnology industry;
• A proven track record of success in implementing and maintaining quality systems and e-systems 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, CLOs, 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;
• A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement;
• Ability to navigate through ambiguity and rapid growth and adapt to change;
• Track record of leading, coaching, and mentoring high-functioning and collaborative teams;
• A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

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Switzerland      Manager and Executive      Manufacturing and Logistics      Quality Assurance      Moderna