Senior Manufacturing Quality Specialist
Description
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day to day work…
You are motivated by working alongside a team filled with
subject matter experts that will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
Kymanox is hiring a Senior Manufacturing Quality Specialist to join our Quality Assurance and Compliance team and play a key role in supporting Kymanox’s clients with compliance activities, with an emphasis on QMS, audits, and gap assessments.
Primary Responsibilities:
- Quality oversight of suppliers (e.g., CMOs, CRS, laboratories, distributors, and specialty services providers), including day-to-day quality support of client programs.
- Batch disposition and review of batch records, QC data, and supporting documentation.
- Quality management system element support (e.g. deviations, nonconforming products, corrective and preventive actions, complaints, change management, supplier management).
- Quality review of technical documentation and regulatory submissions.
- Inspection readiness activities and participation in regulatory body inspections.
- Supplier management activities, including audits of raw material and component suppliers, CMOs, CROs, laboratories, distributors, and specialty service providers.
- Gap assessments against industry regulations or standards and remediation support.
- Design and implementation of Quality Management Systems. Development of policies or standard operating procedures and training (internal and external).
Minimum Qualifications:
- A bachelor's degree in a science-related or engineering discipline.
- 7-9 years of experience in the pharmaceutical/drug, biotech/biologics, cell/gene therapy, and/or medical device sector.
- Diverse background relating to pharmaceutical, biologics or gene/cell therapy development, and/or drug/device combo development, including direct working knowledge of Quality Control, Quality Assurance and/or Quality Enterprise systems.
- Direct experience with, and application of, project management concepts and tools.
- Direct knowledge of statistical analysis and related tools and programs.
- Strong ability to drive program and project initiatives from the concept phase to full implementation.
- Strong business acumen and ability to engage, build, and maintain strong client relationships.
Travel:
This role may require 10-20% remote travel domestically and internationally to Kymanox offices and client sites. A passport is required for this job.
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About Kymanox:
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pride… because patients deserve better.
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.