Sr. Coordinator, Quality

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

Role Overview:

The Senior Quality Coordinator is part of the Novato Quality Leadership Team (NQLT) reporting to the Head of Site Quality in Novato, California. The role is responsible for supporting MSA, NDA and SOW for the head of Global Quality Assurance, Novato Site Quality Head and Head of Product Quality Lifecycle Management Head. The Senior Quality Coordinator will work in a fast-paced environment that requires efficient and timely completion of duties. This role also supports the Novato Site Head of quality in developing and managing visual displays, metrics pertinent Novato Quality. This position requires critical thinking ability, influencing, collaboration, multi-tasking, independent execution, and leadership skills.

Duties:

Develop and maintain visual displays for monitoring key performance indicators for Novato Quality Leadership team.

Manage department budget and associated processes.

Assist NQLT in the creation and maintenance of RACIs and SLAs

Develop and implement NQLT sponsored projects and timelines. Serve as project manager as needed.

Create presentation slide decks as needed.

Attending NQLT staff meetings and serving as a scribe to capture decisions and action log. Maintain NQLT action log.

Initiate and process MSA/NDA and SOW contracts in support of Global Quality Assurance, of Product Quality Lifecycle Management and Novato Site Quality Heads. Onboard New Suppliers in Coupa

Proactively coordinate, create, and manage Novato site visit agenda and itinerary for the Chief Quality Officer (SVP)

Create and maintain distribution lists for Novato Quality. Develop a system for maintaining the lists current.

Manage budget for, plan, schedule and facilitate site quality engagement events

Provide proactive support in managing the Quality Site Heads calendar, including scheduling meetings, coordinating appointments, and ensuring optimal time allocation for business priorities.

Perform other duties as assigned.

Skills:

Excellent interpersonal and communication skills (written & verbal) and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally and at all levels

Demonstrated ability to partner with other functional groups to achieve business objectives.

Demonstrated ability to work independently and effectively.

Demonstrated ability to drive continuous improvement and operating with a Lean and Agile mindset.

Experience in project management is a plus.

Ability to create slide presentations.

Ability to work in a fast-paced environment.

Results oriented; effectively manage multiple projects efficiently.

Demonstrated knowledge in data analytics and visual management tools required.

Experienced in using business related AI tools such as Co-pilot

Proficiency in Microsoft office Suites required.

2+ years' experience in Biotechnology, Pharmaceutical or other regulatory industry preferred but not required.

Education:

BA/BS in life sciences or related field