Associate Director, Quality Assurance
vor 2 Wochen
**The Role**:
Reporting to the Director, QA “Drug Product” Operations, the Associate Director of Quality Assurance QA Operations will be responsible for managing and providing QA oversight and support for contract manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements.
This leadership role located in Basel, Switzerland will implement and manage Quality improvement initiatives and ensure robust processes and systems are implemented across Moderna’s international DP operations.
The AD QA Operations will be accountable for CMO QA oversight, build his team and act as a team leader for the QA Operations staff who is responsible for drug product fill/finish activities in France and other countries if needed. The incumbent will manage and provide person in plant QA presence at contract manufacturing organization (CMO) sites for oversight of drug product fill finish activities and support review and approval of all cGMP documentation including policies/SOPs, testing data, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPA, and Change Controls. 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**:
Manage overall oversight and provide person in plant QA presence at contract manufacturing organization (CMO) sites to adherence to approved policies, SOPS, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation and resolution of any issues and nonconformities.
Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).
Support quality investigations and manage CAPA (corrective and preventative actions) for CMO activities.
Review and coordinate approval of all changes made to the manufacturing, testing and control processes including those that are initiated by CMOs and Contract Laboratory Organizations (CLOs).
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.
Provide QA oversight at contract manufacturing sites to ensure compliance with approved quality agreements and overall cGMP compliance for Moderna’s drug products.
Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management.
This role requires approximately 40% international travel.
**Here’s What You’ll Bring to the Table**:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10 + years.
Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.
Signification experience in product and process transfer.
Ability to interact effectively with all levels of personnel within the organization.
Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
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).
Ability to navigate through ambiguity and rapid growth and adapt to change.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
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 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
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology p
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