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Quality Assurance Manager

3 months ago

Madison, United States Fujifilm Full time

Overview:
The Manager of Quality Assurance will support both the Discovery Research (Research Use Only) and Therapeutic (CGMP) aspects of the Fujifilm Cellular Dynamics, Inc. (FCDI) business. The role supports quality assurance initiatives, ensures implementation of quality systems and compliance with applicable regulations, guidelines, and quality system procedures. The role manages day-to-day operational functions of the Quality Assurance Specialist team, mentoring and developing team members and is a key influencer is creating and maintaining a culture of quality and compliance.

FCDI is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living.

External US:
**Essential Responsibilities**
- Manage the review of documents and records used to support the Discovery Research) and Therapeutic operations, approving quality assurance records.
- Manage the implementation and maintenance for assigned portions of quality assurance systems and their directed activities, ensuring compliance with quality management system policies, as well as applicable regulations.
- Deliver solutions to quality and technical areas such as investigations, root cause analysis, and risk management tools, and making data driven and technical decisions, using critical thinking skills.
- Write, revise, review and approve standard operating procedures.
- Develop, train and retain Quality Assurance Specialist team members to ensure all aspects of manufacturing operations and quality control are fully supported to meet compliance and business expectations.
- Mentor the Quality Assurance Specialist team in quality assurance best practices, setting a clear vision of goals and objectives that are aligned with site and corporate initiatives and following through on them - providing guidance, support, and feedback on team member performance.
- Participate in regulatory inspections and/or external client audits.
- Develop and prepare metrics to measure and drive continual improvement.
- Other job functions as assigned.Onsite

**Required Education and Skills/Experience**
- Bachelor’s degree in a life science discipline such as, but not limited to, cell biology, biochemistry, or microbiology, or its equivalent.
- 3 years of quality assurance experience within a cGMP and/or Life Science environment with demonstrated experience in overseeing product Quality.
- At least one year of supervisory experience; able to train, coach, develop and manage an effective team.
- Functional knowledge of cGMP and regulations including experience participating in regulatory and client audits.
- Proficiency with MS office suite of products.
- Able to work at a computer for extended periods of time.
- Occassional travel of up to 5%.

**EEO/AGENCY NOTES