Moderna is seeking a Quality Assurance Sr. Specialist within the External Quality Assurance department.The first 7-12 months of this work will require being fully on-site based in Fargo, North Dakota but will eventually be fully based in Norwood, MA or Remote.The individual in this role will be responsible for providing quality support and lead Quality improvement initiative related to external manufacturing activities including DNA plasmid materials. The individual will work directly with contract manufacturing and internal functions to ensure robust processes and systems are implemented in support of Modernas CMC commercial and clinical programs. This individual will develop and implement quality systems / standards.The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.
Heres What Youll Do:
Establish collaborative working relationship with CMOs to ensure compliance to regulations and that product quality is ensured.
Ensures adequate process, analytical and documentation transfer by observing the operations at the CMO
Compliance to current Good Manufacturing Practices (cGMP) and Moderna Standard Operating Procedures (SOPs).
Strengthen tech transfer and manufacturing process by providing a dedicated Quality resource who is on site partnered with Moderna Manufacturing Operations team.
QA input for issue investigation/remediation and escalation of site level issues to QA Point of Contact and ensure execute according to the Quality agreement.
Work with Operations and CMO as the Quality Contact to resolve/escalate Quality issues during production, testing, warehousing and distribution.
Allow for real time QA input/assessment of all non-conforming incident-deviations, OOS,
Oversee timely reporting and closure of Quality events- changes, deviations, OOS, complaints
Oversight of change management
Ensure adequacy/completeness of batch record documentation and deviations/comments are documented and are ready for release in a timely manner.
Review and input for generation of new or revised master batch records, SOPs and other controlled documentation. Author quality documents as assigned.
Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)
Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
Review and approve validation protocols and reports to ensure compliance
Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
Support disposition of DNA plasmid materials
Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations
Responsible for proactive monitoring the performance of CMOs/ CTLs & suppliers to ensure that they remain in a state of control are aligned to metrics/ expectations, and leading the effort to drive improvement
Responsible for the development & assessment of quality metrics, KPIs and reports associated with CMOs / CTLs and to recommend actions as a result of such reviews / reports.
Represent QA CMO/ CTL management team with cross functional project team
Responsible to ensure appropriate escalation, communication channels are used ensuring that Senior management are kept informed of critical issues.
Support internal and regulatory agency inspections at CMO. Responsible to work with CMO compliance lead to ensure CMOs/ CTLs are inspection ready.
Support the collection of data/metrics for Management Review
Provide guidance on GMP manufacturing from Phase I to Commercial
Heres What Youll Bring to the Table:
8- 10 years of experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure- with at least 6 years working in process and manufacturing and GMP environment.
Prior experience conducting process transfers, scale up and validations.
Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
Experience working with CMOs, vendors, and relationship management preferred.
Experience working with DNA plasmid materials manufacturing preferred.
Excellent judgment and ability to communicate complex issues in an understandable way.
Outstanding communication skills (verbal and written).
Auditing experience is a plus.
Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.
Knowledge of late-stage pharmaceutical development and validation principles preferred
Ability to manage multiple projects in a fast-paced environment.
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
Travel required up to approximately 50%.
Position may require Person-In-Plant responsibilities up to 6 months at a time
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.
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.