FUJIFILM Biosciences ยท 1 week ago
Associate Director, Quality Assurance
Warminster, PA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$118K/yr - $165K/yr
10+ years expFUJIFILM Biosciences is a company that advances the field of life sciences through innovative products and services. The Associate Director, Quality Assurance will lead the Quality Systems team, ensuring compliance with quality standards and regulations while managing quality assurance processes and personnel.
BiotechnologyManufacturing
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
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 Biosciences
With a foundation in cell culture that dates back to 1970, FUJIFILM Biosciences is a global, full spectrum supplier to the life sciences market, providing products and services that assist customers in advancing healthcare initiatives.
501-1000 employees
H1B Sponsorship
FUJIFILM Biosciences 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
2025 (1)
2024 (2)
2023 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Mayasari Lim
Director of Product Planning and Business Support
Recent News
EIN Presswire
2025-10-15
Company data provided by crunchbase