Global Head, Digital Quality Systems

The Role

Reporting to the VP, Global Quality Systems and Compliance, the Global Head, Digital Quality Systems 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 regulatory requirements related to Modernas digital GxP systems are known, communicated, and implemented across Businesses.

Heres What Youll Do:

• This newly created key position will develop and drive implementation of integrated and sustainable Digital Quality Assurance strategies, and activities for Modernas 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 Modernas global Computer System Validation related standards.

• Partner will Digital Compliance leadership on the development of Modernas Solution Lifecycle policies and procedures related to computer software assurance/validation to ensure global regulatory requirements are achieved in Modernas 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 Modernas 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 minimal 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 Modernas 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 Modernas 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

Heres What Youll Bring to the Table:

• Bachelors 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 leadership

• Biased to reduce complexity and create simple and organized data systems

• Proficiency in creating high quality procedures that are easy to read and understood

• Desire and interest to leverage new technology and innovative information management tools

• Outstanding communication skills (verbal and written).

• Demonstrated problem detection and problem resolution skills

• Ability to take initiative and work independently with minimal oversight

• Must possess demonstrated organizational skills

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary winter shut down
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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