Reporting to the Associate Director, Global QC Specifications & Change Controls, the Senior Manager, QC Specifications & Change Controls US, will be collaborating closely with Moderna's network of QC Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), with the main following responsibilities (not exhaustive):
Here's What You'll Do:
- Authoring Moderna Specification documents for Phase I-IV and commercial products (in close partnership with TD function in terms of overall process and definition of specifications for products in development phases).
- Lead/co-lead Specification relevant Change Controls, applicable locally and globally.
- This position is expected to work in a highly collaborative and cross-functional team environment (including Technical Development groups) also supporting sites in regulatory and third party/HA inspections.
- The individual will also act as liaison person to various groups including External QC US & OUS, Commercial & Clinical QC in US, Site Quality Assurance US, Site MS&T, Regulatory US and Technical Development.
Within the scope of Specification management process:
- Author & review Specification documents, global & local, for Phase I-IV and commercialized products.
- Support definition of specifications & acceptance criteria for Phase III and commercial products.
- Support the definition and implementation of an "end to end" specification management process.
- Be active part of the Specification management process for products in development phases.
- Author and/or review specifications for products in development phases.
- Actively collaborate with Veeva and LIMS System/Business Owner/s to implement the specification management process within the system.
- Support process improvement for Pharmacopoeia Compliance of Moderna testing methods, in partnership with Pharmacopoeia Compliance Lead and with local with AS&T experts.
- Edit/update local and/or global SOP or Policies about specification management process and/or for Laboratory relevant topics.
- Interact for continuous alignment with colleagues from Regulatory Departments.
- Oversee alignment between specifications in Moderna and at affiliated (CTOs)/(CMOs).
Within the scope of Specification Change Controls, globally relevant:
- Act as Change Owner/Coordinator for Specification Change Controls globally & locally relevant.
- Support implementation (Action Owner/SME) of all (local, regional) specification related Change Controls.
- Represent Global QC in any Change Control board (local and global).
- Align always within the extended QC community (including Moderna AD, ATO & QC Labs, Moderna International QC organization and QC Labs from affiliated CMOs/CTOs).
Within the general scope of the role, within Global QC function:
Here's What You'll Bring to the Table:
- Be an active member of Moderna extended QC community, interacting with Commercial and Clinical QC in Norwood, with Moderna International QC organization and, if required, with CMO/CTO QC Labs.
- Support laboratory out of trend (OOT) and out of specification (OOS) investigations.
- Provide technical support, in the context of QC testing, for sites and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections).
- Support AS&T group with regards to Analytical Method lifecycle.
- Support Annual Product Quality Review (APQR) activities.
- Work closely with QC Labs, Digital/IT and AD/ATO to implement automation and introduce novel approaches/technologies to improve overall analytical method performance and throughput (designing QC testing technology capability roadmap).
- Collaborate for proactive identification of risk and compliance issues, manage prioritization of transformational and continuous improvement activities to deliver efficient laboratory solutions.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Bachelor's degree with a 8-10 years of experience in the pharmaceutical industries, 5-8 years of experience with a Master's degree
- Good understanding and experience with US, EU and ICH guidelines and regulations.
- Knowledge and expertise in analytical method lifecycle and transfer management.
- Experience in managing product specifications globally & locally relevant, both in commercial and development phases.
- Experience in coordination of Change Controls affecting QC operations.
- Experience with authoring and review of Quality memo, procedures, policies, risk assessments.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Experience participating in inspections as a Stability/QC testing (SME) and in direct interactions with world-wide/diverse Health Authorities (e.g. FDA, MHRA, EMA, PMDA, ANVISA).
- Ability to interact effectively with all levels of personnel within the organization and externally with CTOs and CMOs. Ability to navigate through ambiguity and rapid growth and adapt to change.
- Proven ability to lead and manage projects/teams of significant scope and complexity, meeting deliverables and timelines (project management skills).
- Experience in assessing, writing, and evaluating OOS's and laboratory investigations.
- 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 person's 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.