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FUJIFILM Cellular Dynamics, Inc · 1 month ago

Associate Director, Quality Assurance

US-PA-Warminster

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$118K/yr - $165K/yr

10+ years exp

FUJIFILM Cellular Dynamics, Inc is a leader in life sciences, offering a comprehensive portfolio of products and services. The Associate Director, Quality Assurance will manage Quality Systems personnel and activities, ensuring compliance with quality standards and regulations while fostering partnerships with stakeholders.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Provides leadership and guidance to the Quality Assurance team to ensure the development and implementation of strategies regarding processes, procedures and quality standards required are maintained in compliance with applicable regulations

Provides ongoing development of the Quality Systems including staff selection, work assignments, goal setting/completion, coaching, development plan review and performance management

Establishes strong partnerships/relationships with business stakeholders

Acts as a quality resource with expertise in quality regulations relating to GMP and ISO guidelines

Direct activities related to the preparation for and conducting inspections and customer activities

Responsible for the performance of the Quality Management Systems (including QA/Validation/Doc control) of the organization

Trend, Analyze Quality Indicators and Key Performance Indicators, responsible for the ongoing

Operation Excellence Program (OPEX). Provide input and direction as to appropriate corrective and preventive actions and suggest plans for improvement based on KPI results

Qualification

Quality SystemsISO 9001/13485ICH/FDA guidelinesManagement experienceMicrobiology/Chemistry/Biology/EngineeringEnglish proficiencyCommunication skillsPresentation skills

Required

B.S. in Microbiology/Chemistry/Biology/Engineering or equivalent education preferred

10 or more years of direct Quality Systems experience in the pharmaceutical, medical device and/or Bio sciences industry

5+ years of Management experience

Detailed knowledge of ISO 9001/13485, ICH/FDA guidelines

Ability to speak, read, and write in English

Good oral and written communication skills and good presentation skills

Benefits

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

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)