Associate Director, Quality Assurance

Fujifilm•Warminster, PA

4d•$117,866 - $165,128•Onsite

About The Position

We are hiring an Associate Director, Quality Assurance. The Associate Director, Quality Assurance will manage Quality Systems personnel and activities for FUJIFILM Biosciences at our Pennsylvania site (Recombinant Growth Factors development and manufacturing) including but not limited to: incoming QA inspection of raw materials, raw material source and qualification program, internal and supplier audit programs, customer audit management, document control, quality control, batch releases, change notification, deviation, complaint, investigation, continuous improvement, audits, validations, system reviews and various customer and internal support as required. At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences). Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

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.

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.