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FUJIFILM Cellular Dynamics, Inc · 2 months ago

Senior Manager, Quality Assurance Technical

US-NC-Research Triangle Park

Full-time

Onsite

Senior Level

7+ years exp

FUJIFILM Biotechnologies is leading the charge in advancing tomorrow’s medicines. The Senior Manager, Quality Assurance Technical provides technical leadership and oversight for QA in a regulated pharmaceutical environment, ensuring compliance with quality and CGMP regulations while managing a team of quality specialists.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Manages a team of quality specialists and sets the direction and priorities to ensure a successful execution of projects and tasks

Assures Quality Management System (QMS) records are on time and creates proactive measures to assure QMS effectiveness

Supports client and regulatory inspections and serves as the subject matter expert (SME) for Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls

Problem solves with the team and determines effective solutions and root causes

Evaluates direct reports performance and addresses gaps appropriately while partnering with HR, as needed

Administers company policies such as time off, shift work, and inclement weather that directly impact employees

Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)

Encourages a culture prioritizing continuous learning and development, including coaching and mentoring to position the team for growth

Participates in the recruitment process and retention strategies to attract and retain talent, as needed

Performs other duties, as assigned

Qualification

GMP manufacturingQuality Management SystemRoot Cause AnalysisPeople managementProblem-solving techniquesContinuous improvementEffective communicationTeam leadership

Required

Master's degree in quality, business management or other related field with 7+ years of related experience; or

Bachelor's degree in quality, business management or other related field with 9+ years of related experience

2-5 years of people management and leadership experience

Prior experience working in a CDMO

Effective communication, both written and oral

Ability to lead teams, projects, and programs while effectively allocating resources

Ability to remain up to date on regulatory and quality requirements

Ability to effectively present information to others

Advanced knowledge of clinical and GMP manufacturing

Ability to continuously improve and utilize the PDCA method and create business processes

Ability to lead problem-solving sessions, such as fish bone, 8-step problem solving, 5 Why's and FMEA

Preferred

5+ years of people management and leadership experience

Root Cause Analysis training

Problem-solving training

Company

FUJIFILM Cellular Dynamics, Inc

Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

Founded in 2004

Madison, Wisconsin, USA

51-200 employees

https://www.fujifilmcdi.com

H1B Sponsorship

FUJIFILM Cellular Dynamics, Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (4)

2021 (1)

2020 (3)