Manager, QC Stability

The Role:

Reporting to the Associate Director of Quality Control Stability, the QC Stability Manager will be responsible for managing direct reports and routine operations of the Clinical and Commercial GMP stability programs while ensuring compliance with SOPs, policies, and industry guidance. In addition, the QC Stability Manager will be responsible for leading, facilitating and supporting US and Global processes for harmonizing and integration of stability-related activities as well as owning and supporting various GMP Quality Systems. This includes, but not limited to, creating, implementing and managing stability databases, performing data trending and statistical analysis, forecasting and reporting of metrics, creation, revision and approval of SOPs, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. The QC Stability Manager will also assist with leading the functionality and maintenance of stability related processes, equipment and systems at the applicable Norwood, MA locations. May require some travel between Modena site locations. May require weekend and holiday support. Remote and onsite support as required.

Heres What Youll Do

• Manages, leads and supports training of direct reports, setting of department goals and compiling/communicating of performance reviews.

• Drives and inspires team to foster an environment focused on continuous improvement activities for the site commercial and clinical stability programs.

• Manages, leads and supports processes for harmonization and integration of stability- related activities i.e. SOPs, stability protocols and data integration amongst sites for Global stability products.

• Authors, reviews, revises and approves SOPs, stability protocols and reports, specification documents (as required).

• Leads, facilitates and executes stability study protocol strategy and design including calculation and execution of stability study setdowns and pulls both independently and through direct collaboration with key cross-functional teams.

• Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.

• Authors, reviews and approves supporting memos and reports including those for expiry, interim/final stability reports and Annual Product Quality Reports.

• Manages, leads and owns Quality Systems(eQMS) records for QC Stability- creates, assesses, reviews and approves Deviations, Change Controls, CAPAs and other applicable stability-related investigations and events.

• Leads, supports and participates with site inspection readiness and audit activities.

• Authors and reviews applicable stability sections of Regulatory submissions.

• Coordinate with appropriate lab management teams to ensure scheduling of stability sample submission and testing and reporting of data.

• Manages, leads and supports stability inventory management activities for all GMP Stability drug substance and drug products that are received, stored and removed for testing.

• Facilitates, leads and supports all activities for stability team meetings.

• Creates, manages and updates stability study trending dashboards.

• Reports and communicates stability metrics at QMR and to key stakeholders in a timely manner.

• Performs stability data trending and supports statistical analysis activities for shelf-life.

• Manages, leads and supports the organization and execution of shipments to off-site storage and laboratory facilities.

• Manages and ensures maintenance, calibration and operation activities for stability chambers to include unit performance including excursion evaluations and resolves any issues.

• Manages stability schedules for GMP stability drug substance and drug product and ensures stability sample pulls occur as scheduled and within appropriate timelines.

• Ensures the initiation and management of stability studies in LIMS.

• Ensures stability data entry and review are initiated and completed in LIMS.

• Evaluates workload and capacity and recommends headcount, equipment needs etc.

• Supports Reference Standard and Cell Bank Stability Program management as required.

• Ensures compliance with cGMP and safety requirements.

• Other duties as required.

Heres What Youll Bring To The Table

• BS with a minimum of 5-7 years Quality Control experience in a Commercial/Global cGMP Quality Assurance/ Quality Control Biotech or Pharma setting with a focus on Stability (preferable in life science or equivalent) and a minimum of 2-4 years or more of leadership/management experience including involvement with regulatory audits and inspections.

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 year-end shutdown
  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.

-