- Responsible for development, implementation, and maintenance of the quality system, promotion of regulatory requirement awareness throughout the organization, and coordination of activities relating to the quality system.
- Administering documentation and records within a paper-based and an electronic quality management system, supporting Quality Control (QC) for product release, and informing the US Orgenesis VP of Quality Assurance of on-site quality issues.
- Plan, implement, and maintain the quality management system in accordance with 21 CFR Part 210 and 211 and other quality systems as needed.
- Generate and implement quality objectives at the site, consistent with and in coordination with the Company's quality team.
- Understand and communicate regulatory requirements to the site and within the Company's global organization.
- Administer the paper based QMS and the eQMS, to include validation and SOP generation.
- Perform on-site recording of QMS data (collect/scan/email/post records)
- Manage and document quality issues (CAPA, Complaints, deviations, etc.) to include investigations.
- Coordinate and support internal and external quality audits, to include regulatory audits.
- Direct supplier qualification, maintenance, and auditing activities
- Perform quality training of personnel and contractors.
- Assist in onsite office management (setting up team teleconferences, purchasing)
- Complete and maintain training in all standard operating procedures necessary to release products.
- Prepare and support all paperwork, including Batch Production Records associated with each production run.
- Work with others to ensure timely and appropriate cross-functional alignment for each assigned project.
- Minimum seven years of relevant experience; two years in a managerial role and five years of relevant GMP experience; experience in a regulated industry preferred (medical device, pharmaceuticals, ISO 17025, etc.).
- Working knowledge of cGMP/cGTP regulations.
- Direct working experience in the field of cell and tissue therapy preferred.
- Direct working experience in a cleanroom environment.
- Minimum of a Bachelor's degree in Science or Engineering discipline or related field is required; an advanced degree (e.g., Master's, Ph.D.) is highly desirable.
- Basic understanding of cGMP (current Good Manufacturing Practices) and cGTP (current good tissue practices) per 21 CFR 1271.
- Ability to work independently.
- Effective communication (both oral and written) and interpersonal skills, with the ability to collaborate with stakeholders at all levels of the organization, both in-person and remotely.
- Experience working with the principles and techniques of data analysis.
- Ability to obtain comprehensive understanding of product specifications and functionality.
- Ability to manage multiple projects and priorities and adapt quickly to changing circumstances.
- Strong leadership qualities, with a demonstrated track record of building high performance teams with strong cross-functional relationships.
- Excellent problem-solving and decision-making skills, with the ability to navigate complex issues.
- Proactive, results-oriented mindset with a demonstrated ability to drive change and deliver high-quality results within established timelines.
- Ability to work under pressure and constantly adjust to the demands of various projects.
- Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, and Adobe Acrobat).
- Fluency in English; additional language skills would be a plus.
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QA Site Lead - Folsom, United States - Orgenesis
4 weeks ago
Description
Job Description
Job DescriptionOVERVIEW:Job Title: Quality Assurance Site LeadReports to: Vice President of QADepartment: Quality AssuranceDirect Reports: NoneLocation: Folsom, California (On-Site)FLSA Category: Full-Time; Exempt Compensation/Salary: D.O.E.
DUTIES/RESPONSIBILITIES:
If you are interested in this position, please click apply We offer a competitive salary, benefits package, and a dynamic work environment with opportunities for growth and advancement. Please note that although we appreciate your interest, only qualified candidates will be contacted.
ABOUT US
Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell and Gene Therapy Biotech Platforms, with the goal of providing life changing treatments at the Point of Care to large numbers of patients at low cost. At Orgenesis, we aim to improve the accessibility and affordability of cell and gene therapies by providing innovative solutions, such as our OMPUL (Orgenesis Mobile Processing Unit and Labs) platform. Our Point of Care Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of life-saving therapies.
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