Sr. Specialist, Quality Assurance, Drug Product

The Role:

Moderna is seeking a Sr. Specialist of Quality Assurance based in Modernas Norwood location. The individual in this role will be responsible for providing Quality support and lead Quality improvement initiatives related to Drug product operations. The individual will work with internal functions to ensure robust processes and systems are implemented in support of Modernas CMC development programs. This individual will develop and execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems. This Role will be 1st Shift Monday through Friday.

Here's What Youll Do:

• 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

• Perform verifications of packaging labels

• Maintain accurate records of all inspection activities

• Support manufacturing vial visual inspections

• Support Product/Room change overs

• Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans

• Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations

• Conduct internal audits, track progress, and trend results

• Provide guidance on GMP manufacturing and on the floor support

Heres What Youll Bring to the Table:

• BS or Masters level degree with at least 3-5 years of experience in the pharmaceutical/biotech industry

• Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

• Experience working with aseptic fill and finish, visual inspection and package / labeling of vials preferred.

• Auditing experience is a plus.

• Knowledge of late-stage pharmaceutical development and validation principles preferred

• Excellent judgment and ability to communicate complex issues in an understandable way.

• Outstanding communication skills (verbal and written).

• Ability to manage multiple projects in a fast-paced environment.

• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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