Global Head, Digital Quality Systems

vor 9 Stunden

Basel, Schweiz Moderna Therapeutics Vollzeit

The Role
Reporting to the VP, Global Quality Systems and Compliance, the Director of Global Digital Quality Standards and Compliance will be responsible for setting, communicating and overseeing creation and management of a Quality led
- Global Quality Digital Quality Management and Compliance function. This role will have the remit to create a digital quality assurance program and related processes to support the development of digital data and validation standards, provide timely feedback on digital and predicate rule regulatory and compliance requirements, working collaboratively across all sites and stakeholder functions to ensure GxP r egulatory requirements related to Moderna’s digital GxP systems are known, communicated, and implemented across Businesses.

**Here’s What You’ll Do**:
This newly created key position will develop and drive implementation of integrated and sustainable Digital Quality Assurance strategies, and activities for Moderna’s clinical and commercial products supporting a robust compliant lifecycle for the digital programs.

This role is highly visible within the Global Quality team, working to help define this new function and identifying solutions and processes, and aligning with key partners on implementation of new requirements as Moderna evolves its digital strategy for QA and for its GxP systems

Drive strategy and direction of CSQA to ensure and sustain compliance of digital solutions and technologies with Moderna’s global Computer System Validation related standards.

Partner will Digital Compliance leadership on the development of Moderna’s Solution Lifecycle policies and procedures related to computer software assurance/validation to ensure global regulatory requirements are achieved in Moderna’s digital solutions and technologies.

Serves as senior advisor to Leadership teams and Process Owners for all CSV compliance related matters and provides leadership consultation and education to Digital and QA teams regarding compliance and validation questions and issues.

Build Digital Operational Excellence with collaboration of Business Process Owners and Digital Partners to ensure that digital solutions and technologies are aligned and successfully implemented with the highest standards of compliance and integrity to meet business needs.

Drive strategic maturity of Moderna’s Data Integrity program. Define rules of engagement and execution of embedding requirements and assessment with solution and system onboarding and change management processes.

Partner with Digital Compliance on establishment of a Computer Software Assurance/Validation Center of Excellence to foster collaboration and awareness of regulatory requirements and expectations, Industry Best Practices, emerging technologies, and internal business practices.

Partner with Supplier Quality Assurance and Digital to establish, maintain and oversee requirements for Technology Supplier (SaaS, IaaS) to ensure compliance with quality system standards and internal policies and procedures.

Drive strategic maturity of the CVS Audit Program to enable risk-based CSV approach and mínimal standards of acceptability of testing verification.

Understand outputs from self-inspections, audits, and vendor evaluation activity and impact on compliance health. Lead cross-functional teams focused on compliance related issues and remediation activities to address critical compliance gaps.

Ensure Inspection Readiness process is executed for supported area

Lead and Mentor a diverse and inclusive global CSQA team, including adaptability/versatility, business and digital knowledge risk-based decision making and value driven right sizing.

Manage workload of global CSQA team and assist personnel with resource contention and prioritization.

Ensure CSQA priorities are aligned with Moderna’s strategic and business areas objectives and initiatives.

Oversee and/or sponsor streamlining and simplification initiatives within CSQA organization as well as those that impact business areas.

Promote a strong Quality Culture to ensure business and technology teams adopts a quality mindset that is fundamental to ensure Moderna’s digital solutions and technologies implementation and usage is fit for intended use and ensures highest level of Data Integrity. Compliance with all global regulatory standards and requirements is a natural byproduct of a strong Quality culture

**Here’s What You’ll Bring to the Table**:
Bachelor’s Degree with minimum of 8-10 years in biopharma experience working within a regulated digital environment

Active experience in participating in Professional Pharm Industry organizations (e.g. PDA, ISPE, RAPS, etc)

Comprehensive knowledge of GXP regulations for document and records management

Ability to interact effectively with all levels of personnel within the organization.

Reputation for superior customer service with excellent interpersonal skills

Strong cross-functional and matrix team leadershi

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