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Senior Manager, Quality Assurance Systems and Compliance
3 months ago
This role is an exciting opportunity to be a part of the Quality Assurance organization. Moderna is a growing organization with a state-of-the-art cGMP manufacturing facility in Norwood, MA, USA. The site focuses on manufacturing early phase and commercial product.
As the company grows, the Quality Assurance is looking for talented individuals with a strong Quality Culture mindset and ability to adapt to a fast-paced environment.
This role will be supporting many of the responsibilities listed below and will be expected to collaborate with cross-functional departments to maintain and enhance compliance at the Norwood site.
We work collaboratively as a team, we boldly strive for excellence, we are constantly curious and committed to ongoing learning and improvement, and we are relentless in our pursuit of having the highest level of Quality products.
Here's What You'll DoManage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity via maintenance and execution of Quality Management Review and Site Quality Council governance forums.
Support the establishment and reporting of quality metrics for cGMP related functional areas.Author and review SOPs and Policies to ensure compliance and adherence to regulations/cGMP operations.
Author, review, and approve Annual Product Quality Reviews (APQR) and other trend reports.
Partner cross-functionally to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees.
Continue to improve Moderna's overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.
Identify opportunities for quality system improvements.
Work collaboratively with the digital team on the GXP integrated digital landscape to support eDOC, eQMS, and LMS systems.
Within 3 Months, You Will...
Complete required onboarding and training programs, familiarize with company policies, procedures, and quality systems.
Start developing relationships with key stakeholders.
Understand the current state of compliance and quality systems.
Within 6 Months, You Will...
Participate in development of strategic plans for quality system and compliance improvements.
Establish regular communication channels for updates and feedback.
Fully own coordination and execution of Quality Management Review and Site Quality Council meetings.
Within 12 Months, You Will...
Act autonomously to identify compliance risk and continuous improvement opportunities.
Demonstrate tangible improvements in quality systems and compliance metrics, establish yourself as an influencer within the organization, and contribute to broader organizational goals and initiatives beyond the quality systems and compliance realms.
Bachelor's degree with a minimum of 10 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.
Fluent in written and spoken English.Experience in data analysis, statistical evaluation, and trending of data.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.
Ability to interact effectively with all levels of personnel within the organization.
Ability to navigate through ambiguity and rapid growth and adapt to change.
A desire to make an impact as part of a high-growth, transformational company that is
Bold, Relentless, Curious, and Collaborative.
Here's What You'll Bring to the Table (Preferred Qualifications)
Master's degree with a minimum of 8 years of experience in the pharmaceutical industries or Ph.
D.
with a minimum of 5 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.
Deep understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.Advanced experience in data analysis, statistical evaluation, and trending of data.
Capability to lead and train a diverse, multinational community of practice with multiple stakeholders.
Proven ability to lead and manage projects/teams of significant scope and complexity, meeting deliverables and timelines (project management skills).
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:
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, the infrastructure 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 people
are 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.
Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visitto 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.
We're 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 contact the Accommodations team at.
(EEO/AAP Employer)
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