Sr. Manager, Digital Compliance

The Role

This role is an exciting opportunity join our Digital Compliance organization as the Sr. Manager to manage Modernas growing digital compliance team to support the global digital landscape to ensure that digital technologies are implemented and maintained with full proficiency and adherence to Modernas internal policies and procedures and regulatory expectations.

The role will be accountable for regulated digital systems operational support. The role will collaborate with cross-functional stakeholders to support both compliance and management strategies. The idea candidate is innovative, detailed oriented and motivated by improving business and compliance outcomes.

This position will be located in Cambridge, MA.

Heres What Youll Do

• Demonstrate proficiency in compliance to Modernas System Development Lifecycle (SDLC) operational controls to effectively communicate the applicability of the controls, drive collaborate in defining solutions and remediation that drive objectives without compromising the effectiveness of the controls.

• Manage a team of compliance professionals to support quality events, and ongoing operations according to the SDLC, and operational controls (change management, incident management, security and data integrity, computer system periodic review).

• Oversee compliance of Digital related quality systems events (Deviations, CAPAs), participate in investigations and root cause analyses, participate in Quality Systems weekly meetings and forums to ensure investigations, root cause analyses and corrective actions drive behaviors to prevent recurrence.

• Manage the Computer System Periodic Review Program and maintain schedule of execution. Ensure adherence to requirements, re-evaluated review frequencies, and update governing procedures.

• Review and approve Computer Systems Periodic Reviews and support investigations to periodic review findings, and drive associated quality events and investigations to closure.

• Review and approve IT/Digital Quality Events, Change Control records for Computer Systems

• Manage (monitors and addresses) compliance activity, ensuring quality, adherence, and improvements to technical, security, and compliance standards.

• Develop dashboards and reports utilizing data visualization to communicate Compliance results to all levels within the organization (Digital and Quality Review Boards).

• Proactively identify continuous improvement opportunities for Digital Systems Operational Controls and the existing System Delivery Lifecycle (SDLC) and Computer System Validation Program as new or revised industry regulations emerge.

• Provide support for Internal and External Audits and Health Authority Regulatory Inspections as needed, acting as subject matter expert

Heres What Youll Need (Minimum Qualifications)

• Bachelors degree in engineering, science, technology or another relevant academic discipline physical science or related field or relevant experience.

• 10+ years of implementing and maintaining technology to support compliance processes in a regulated biotech or Pharma company

• Experience with SAP, Veeva Quality Vaults (eDMS and eQMS), SAP SuccessFactors Learning Management, KneatGx Validation Management System, ServiceNow, or similar technologies

• API, data report development and systems integration

Heres What Youll Bring to the Table (Preferred Qualifications)

• Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions

• Quality orientated with strong attention toward detail

• Self-directed with effective analytical and problem-solving skills to make sound and timely decision to achieve expected results

• Ability to navigate through ambiguity and rapid growth and adapt to change

• Ability to react under pressure to any given situation that may arise, in a professional manner and with positive results, in support of a multi-location, 24x7 environment.

• Ability to work hard to effect change in a dynamic, high standards environment while maintaining a positive approach with management and peers.

• Highly collaborative work style. Strong interpersonal skills with the ability to build successful professional working relationships.

• Ability to work effectively in a cross-functional, fast-paced project environment.

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer systems SOX, CSV, data integrity

• Technical writing skills required

• A digital first and curious mindset that allows you to constantly learn and challenge the status quo

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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