Quality Management System Specialist
Quality Management System Specialist
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Job Description
About Frontier
Frontier is a subsidiary of Fresh Prints. Fresh Prints is a New York based fastgrowing fullyremote 150person company that has most of our team in India and Philippines. A few years ago Fresh Prints started helping other fastgrowing companies build their teams. We got so good at it that we decided to spin out a new company to focus exclusively on that and call it Frontier.
Here at Frontier we help companies grow fulltime crossfunctional teams abroad. We hire the smartest people and we place them into the best companies. In three years weve never lost a client.
If you like one of the Frontier roles and you apply and youre accepted well screen you with a couple of internal interviews and will work on getting you an interview for a fulltime job within the month.
Think of us as your personal talent agent and good luck with the application :)
One of our clients Oak Hill Bio is looking to hire an QMS Specialist.
About The Role
Oak Hill Bio a new biotech dedicated to developing lifechanging medicines for rare and autoimmune diseases that impact patients across their lifespan is looking for an experienced QMS Specialist. We are building a team of intelligent hardworking and collaborative individuals dedicated to bringing these therapies to patients in need. Oak Hill Bio is a fastgrowing firm offering the opportunity for extraordinary professionals to take on a major responsibility and drive results.
QMS Specialist Position Summary
The QMS Manager will play a critical role in maintaining Oak Hill Bios Quality Management System (QMS) with a strong focus on Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) compliance. This position is ideal for a selfstarter QA professional with GxP experience who thrives in a fastpaced crossfunctional environment and is motivated by a missiondriven culture.
Key Responsibilities:
Quality System Oversight & Compliance
- Maintain and update QMS documentation including SOPs policies and templates in alignment with global GCP and GMP regulations under the direction of the Senior Director QA.
- Manage deviation tracking implement CAPAs and ensure uptodate quality logs.
- Oversee ACE eQMS system and ensure all GCP and GMP QA documentation is filed and up to date.
- Maintain eQMS records received from CMC and Clinical Supplies.
Audit Management
- Compile annual audit plan for GXP vendors.
- Coordinate and manage internal and external audits focused on GCP and GMP according to the annual audit plan.
- Review audit reports track resolution of findings and oversee CAPA execution by auditees (internal and external).
Vendor Qualification
- Maintain the Approved Vendor List.
- Maintain Vendor Qualification records in the eQMS.
- Ensure all vendor documentation and quality agreements are up to date and filed in the eQMS.
Inspection Readiness
- Administrative support of GCP inspection preparedness activities organizing training documentation review and site visit support.
- Support QA execution of the inspection plan when inspections are announced and preparation of responses to inspection findings.
- Ensure compliance with regulatory expectations.
Training Record Management
- Maintain training compliance metrics.
- Deliver training sessions on GCP and quality best practices to crossfunctional teams.
- Monitor and provide compliance advice in relation to the QMS.
Quality Metrics & Reporting
- Maintain metrics for audit vendor qualification CAPA and deviations and other outputs of the Quality Management System.
- Prepare metric reports from the eQMS for quality management review meetings.
Qualifications:
- Bachelors degree in life sciences or a related field.
- 25 years experience in Quality Assurance within the clinical research or pharmaceutical industry with a primary focus on GCP or GMP.
- Indepth knowledge of global GCP (Clinical development QA or compliance) and/or GMP regulations or specialist knowledge in CMC compliance.
- Strong organizational interpersonal and communication skills.
- Proven ability to manage multiple projects and collaborate with diverse stakeholders.
- Attention to detail and meticulous record keeping skills.
- CSV experience and data integrity knowledge a plus.
Why Join Oak Hill Bio
This is an opportunity to make a meaningful impact at a company committed to scientific innovation and patientfocused development. Youll work alongside experienced leaders in a supportive and forwardthinking environment.
Required Experience:
Unclear Seniority
Employment Type
Full Time
