Batch Release Coordinator Quality Assurance Disposition

Jobinhalt

The Role

The Batch Release Coordinator for the QA Disposition team will provide QA oversight and support of Moderna’s international organization’s product disposition of clinical and commercial product manufactured at contract manufacturing organizations (CMO) and tested at contract laboratory organizations (CLO). The Batch Release Coordinator will ensure that release activities for clinical and commercial drug substance and drug product as well as labeled and packaged product are completed on time and in accordance with cGMP, international regulatory requirements, internal policies, procedures and specifications. The incumbent will coordinate the related activities with Manufacturing, MS&T, Development, 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 work with Qualified Persons (QP) /Responsible Persons (RP) 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

• Review and approve disposition documentation to certify compliance with cGMP and international regulatory requirements and internal policies, procedures and specifications.

• Prepare and review certificates of compliance in support of product disposition.
• Support overall disposition process to ensure on time disposition per approved and defined turn-around times to meet supply and customer requirements and timelines.
• Establish an adequate batch release monitoring process, including the definition of key quality indicators and use of tools such as dashboards.
• Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).
• Take part in the deviation handling process (for example, temperature excursions) and the complaint management process as part of his/her involvement on the QA oversight of Moderna International GDP related activities.
• 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), Development, 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 Person (QP) and Supply Chain (SC).
• Manage the release inbox and ensure release documentation is provided to customer and health authorities on time as well as he/she will ensure the customer or health authorities queries are appropriately responded to.
• Lead continuous improvements with regards to the Distribution and Disposition processes in order to ensure efficient and compliant GDP processes.
• 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 5-8 years.

• 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.
• Experience in GDP processes oversight, including temperature excursion handling.
• 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.
• 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.
  

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

Moderna is a smoke-free, alcohol-free and drug-free work environment.