Sr Quality Assurance Specialist, Supplier Management and Audit

ResponsibilitiesAssist with GxP audits (GMP, GDP, GLP) of suppliers, contract manufacturers, and internal departments.Participate in internal and external audits.Lead supplier qualification, requalification, and ongoing performance monitoring.Evaluate supplier quality systems, risk levels, and compliance gaps, and ensure timely closure of CAPAs.Develop, negotiate, and maintain Quality Agreements with external partners.Monitor supplier metrics, deviations, complaints, and change controls to ensure sustained compliance.Support regulatory inspections by providing QA expertise on supplier oversight and audit programs.Collaborate with cross‑functional teams—Supply Chain, Manufacturing, Regulatory etc, to align quality expectations and mitigate risks.Contribute to continuous improvement initiatives within the Quality Management SystemDevelop and maintain productive working relationships with Operations, Product and Process Development and Quality Control departmentsWork on problems of diverse to complex scope in which analysis of situation or data requires evaluation of a variety of factors.QA SME for DOT compliance electronic Quality Manage System, Audit and Supplier modules.QA oversight of workflows within DOT.Skills requiredStrong understanding of GxP regulations, ICH guidelines, and global regulatory frameworks.Proficiency in auditing techniques and risk‑based quality management.Excellent communication, documentation, and stakeholder‑management abilities.Analytical thinking with the ability to interpret quality data and identify trends.Ability to manage multiple audits and supplier relationships in a compliance‑driven environment.Strong written and verbal communication, organizational and prioritization skills.Ability to handle multiple priorities in a project driven environment.Ability to maintain a flexible and a customer-oriented approach to problem-solving.Ability to maintain detailed and accurate records.Familiarity with electronic Quality Manage Systems, (DOT compliance, Veeva, Trackwise etc)Education and experienceBS in scientific or related discipline.Minimum 8 years cGMP experience in Quality Assurance.Industry experiences in medical devices ISO 13485 and/or FDA 21 CFR regulations for Drug Product manufacturing.Certified Auditor.Proficient in the use of a wide variety of computer applications including the MS office, Excel, data base management systems, and project management software.Physical RequirementsProlonged periods of sitting at a desk and working on a computerPotentially prolonged periods standingMust be able to lift up to 15 pounds at timesMust be willing to travelCompensationThe base salary for this role starts at $138,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health benefits and an annual target bonus for full-time positions.

Salary : $138,000