30 applicants
Kolon TissueGene, Inc. · 4 days ago
Sr. Quality Assurance Manager
Rockville, MD
Full-time
Onsite
Senior Level
5+ years exp
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Hiring Manager
Vaidehi Hussain
Insider Connection @Kolon TissueGene, Inc.
Responsibilities
Works closely with Manufacturing regarding product quality planning, design and improvements to ensure Quality is built into manufacturing processes.
Supports Internal audits and external vendor audits including leading audits and providing the required reports and documentation.
Performs change control assessments to Quality Systems including document management, change control and CAPA.
Approves Deviations and CAPAs and ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address the root cause.
Acts as Quality Subject Matter expert and represents Quality in internal and vendor meetings.
Collaborates with manufacturing, clinical and regulatory groups to ensure site quality.
Manages the QA review of Batch Records
Manages SOP review process and assists in identifying gaps.
Communicates changes in regulations and practices to the organization effectively and in a timely manner and aids in the development of plans to address these changes.
Interacts with Regulatory Affairs, and Manufacturing to ensure that regulatory submissions meet domestic and international standards and regulatory requirements.
Other Duties as assigned.
Qualification
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Required
A minimum of Bachelors degree in a scientific discipline
A minimum of 5 years Quality Assurance Experience
A minimum of 3 years of experience in a Quality Assurance people management role
Demonstrated mastery/understanding of Quality Systems and Quality controls.
Detailed working knowledge of cGxP requirements and current FDA regulations.
Experience in the preparation of IND and BLA applications
Strong interpersonal skills: team building, consensus building, and conflict resolution
Well organized and detail oriented with strong verbal and written communication skills.
Benefits
Comprehensive health and wellness benefits package.
Opportunities for professional development and career growth in a dynamic industry.
Company
Kolon TissueGene, Inc.
2-10 employees
H1B Sponsorship
Kolon TissueGene, 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
Trends of Total Sponsorships
2022 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$89.73M2023-05-15Post Ipo Equity· $30M
2022-08-26Post Ipo Equity· $29.64M
2021-12-16Post Ipo Equity· $30.09M
Leadership Team
Sun Jin Kim
Chief Medical Officer
Company data provided by crunchbase
