Batch Release Coordinator, QA Disposition - Basel, Schweiz - Moderna Therapeutics

Moderna Therapeutics

Geprüftes Unternehmen

Basel, Schweiz

vor 2 Stunden

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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.

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.

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 h