Senior Manager Product Quality Lead

The Role:

Reporting to the Director, Global Quality Operations, the Senior Manager, Product Quality Lead will be responsible for developing, approving, monitoring, and maintaining critical quality standards ensuring quality management of products and processes lifecycle, leading improvement, and alignment with current regulatory expectations.

The individual will ensure robust processes are implemented across Modernas global operations for management of product and process lifecycle quality (control strategy, technical transfer and changes, process validation lifecycle, quality monitoring). In collaboration with the Global Quality Systems and Compliance team, this individual will support continuous improvement of Modernas Global Quality Management System. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

Heres What Youll Do:

• Develop and deploy policies/SOPs/standard reports/KPIs for management of continued process verification, Technical Transfer and Control Strategy, in collaboration with Technology Development (TD), Manufacturing Sciences and Technology (MST),Regulatory Affairs (RA), Quality Control (QC), Quality Assurance (QA), Manufacturing (MFG), and Facilities and Engineering (F&E)

• Coordinate deployment and application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality.

• Coordinate APQR process execution within network of internal, external and international partners to ensure appropriate documentation are delivered in a timely manner.

• Act as global Quality representative in cross-functional forums to provide support and oversight to internal and external manufacturing and testing facilities for application of Global Quality Management System, policies, SOPs and Standards throughout commercial lifecycle of products.

• Provide quality support for significant changes and issue management (Deviations/CAPAs) across Modernas internal and external manufacturing and testing sites

• Contribute to improvement and harmonization initiatives across Global Quality Operations.

• In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System.

• In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes.

Heres What Youll Bring to the Table:

• Bachelors degree, preferably in Sciences or Engineering with applied Quality industry experience of 8-10 years; 5-8 with MS.

• Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.

• Experience in prefilled syringe process validation, experience in Medical device as QA engineer is a plus.

• Working knowledge of control charts and statistics applied to process validation and data trending using statistical programs and software (e.g, JMP, Looker, Statistica, Spotfire)

• Experience in management or application of quality systems and e-systems in a biopharma organization.

• Experience in computerized systems, automation, manufacturing,and testingwithin biotechnology industryis a plus.

• 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 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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