https://amzn.to/44P6GXZ
The Role
In this role, you will be responsible for building a comprehensive Research & Development Quality (RDQ) Training and Competencies Program. You will contribute to the development of the processes necessary to support the Training and Competencies Program. You will also support the development of the RDQ Audit Management function. The individual will primarily work with RDQ staff to create a GCP, GCLP, GLP, GVP, and CSV cross-functional training program for RDQ staff. This individual will drive continuous improvement of clinical, pre-clinical, pharmacovigilance and computer system validation services to the Moderna R&D organization. Works on assignments requiring considerable judgement and initiative. Understands implications of work and makes recommendations for solutions. The successful candidate must have experience in a biotech or pharmaceutical GXP environment.
Here’s What You’ll Do:
Drive the creation of the RDQ Training & Competencies Program by:
Building, executing, and maintaining a RDQ cross-functional training program which will include periodic reviews and updates
Developing a skills matrix designed to monitor and track RDQ staff and consultant competencies
Assist in audit planning and scheduling activities within the organization
Providing input, as applicable to the development of RDQ and R&D policies and procedures
Actively participate in implementing new strategies, innovation, and solutions to the RDQ Training and Competencies Program
Perform other RDQ tasks as assigned by line manager
Participate in regulatory authority inspections, as necessary
Contribute to the continuing development of a quality culture at Moderna
Travel to support regulatory agency inspections required
Here’s What You’ll Bring to the Table:
BS/BA, or MS or a minimum of 8 years of experience, respectively, in Biotech, Pharma or a Clinical Research Organization
Strong knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international regulations, guidelines, and local legislation
Experience managing and maintaining a cross-functional training program and skills matrix
Strong interpersonal skills with the ability to effectively organize and execute tasks
Ability to interact effectively with all levels within the organization
Ability to work both independently and in a team environment
Excellent analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment
Excellent communication and presentation skills, both verbal and written
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
Ability to influence and negotiate effective solutions, excellent interpersonal skills
Experience with electronic Quality Management Systems (e.g., Veeva, Master Control)
Travel up to 20% based on business need.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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 (url removed).
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
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