Lead the day‑to‑day execution and administration of the Quality Assurance vendor and audit management program, coordinating audit lifecycle activities, managing vendor quality documentation, and ensuring compliance with GxP and regulatory requirements.
Locations (2)
Princeton, New Jersey, United States
Pleasanton, California, United States
Compensation
The pay range for this position at commencement of employment is expected to be between $131,750- $155,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
Responsibilities
Coordinate operational lifecycle of assigned GxP audits
Schedule audits and coordinate logistics with auditors, vendors, and internal stakeholders
Support audit preparation and documentation collection
Maintain audit records and track activities in TrackWise Digital
Escalate compliance concerns and emerging risks
Requirements
Bachelor’s degree in a scientific, technical, quality, or related discipline
Nice to have: 7+ years of pharmaceutical or biotechnology QA experience
Nice to have: Experience in regulated pharmaceutical or biotechnology environment
Lead the day‑to‑day execution and administration of the Quality Assurance vendor and audit management program, ensuring compliance with GxP and regulatory expectations.
Locations (2)
Princeton, New Jersey, United States
Pleasanton, California, United States
Compensation
The pay range for this position at commencement of employment is expected to be between $131,750- $155,000 annually.
Responsibilities
Coordinate the operational lifecycle of assigned GxP audits, including vendor audits and other Quality audits
Schedule audits and coordinate logistics with auditors, vendors, and internal stakeholders
Support audit preparation by collecting relevant documentation and ensuring required information is available
Maintain audit records and track activities through report issuance, response, CAPA management, follow‑up, and closure
Monitor commitments and due dates and follow up with responsible stakeholders to support timely completion
Responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, and for keeping them inspection-ready, while strengthening the Quality Management System infrastructure as a business partner across GxP and corporate quality functions.
Compensation
The expected annual base salary range for this role is $170,000.00 to $190,000.00.
Responsibilities
Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
Support the integration of new business processes, departments, and vendors into the Quality Management System, and oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
Administer the training program: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for core quality processes, including document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
Requirements
Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline
The Document Control Supervisor is responsible for overseeing the daily operations of the Document Control department to ensure the accuracy, integrity, and compliance of controlled documentation within the organization's Quality Management System (QMS).
Responsibilities
Supervise the daily activities of the Document Control team, ensuring work is completed accurately and within established timelines.
Assign, prioritize, and monitor workloads to meet departmental and business objectives.
Manage the document lifecycle, including document creation, review, approval, revision, distribution, archival, and retirement.
Ensure all controlled documents are maintained in accordance with company procedures and regulatory requirements.
Administer and maintain the Electronic Document Management System (EDMS), ensuring document integrity, version control, and audit trail accuracy.
Requirements
Bachelor's degree in Business Administration, Life Sciences, Engineering, Quality, or related field
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