Moderna is seeking an Associate Director, R&D Quality, reporting to the Vice President of R&D Quality. This person will be responsible for the design, development and implementation of a Quality Management System (QMS) for Research & Development (R&D). The individual will primarily work with the R&D organization (e.g., Clinical Development Organization (CDO), Safety, Non-Clinical, etc.) and R&D Quality colleagues to ensure development of a QMS that is fit for purpose for R&D including all applicable elements of a QMS (i.e., Policies & Procedures, Knowledge Management, Issue Management, etc.). This individual will also be responsible for conducting periodic assessments of the R&D QMS to facilitate continuous improvement and to maintain an awareness of the health of the QMS. This individual will support the R&D QMS and drive continuous improvement of clinical, pre-clinical and pharmacovigilance 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 GCP, GLP and/or GVP environment.
location: Cambridge, Massachusetts
job type: Permanent
salary: $128,000 - 140,000 per year
work hours: 9 to 5
- Execute and/or oversee assessment of the R&D QMS
- Partner with R&D functions (e.g., Clinical Development, Safety and Non-Clinical) to collaborate
- Aide in the establishment and maintenance of R&D policies and procedures
- Review, approve, maintain procedural documents (e.g., policies, procedures, etc.)
- Track procedural documents for periodic review/revision to ensure continued applicability to Moderna practices
- <5-10% Travel
- BS in a scientific discipline with at least 12 years' experience in pharmaceutical / biotech industry within Quality Assurance and/or Quality Management Systems
- Preferably prior experience in GCP, GLP, GVP auditing or operations experience
- Outstanding communication skills (verbal and written)
- Ability to manage multiple projects in a fast-paced environment
- Familiarity with Veeva
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Has advanced understanding of R&D Quality Management Systems and applies knowledge and skills to complete a wide range of tasks. Familiar with a variety of the field's concepts, practices, and procedures.
- High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goals.
skills: GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.