Senior Manager, Quality Systems and Compliance
A
ApnimedPharmaceutical quality
We are generally virtual and specific location within the US is not critical.Full-TimeManager
Salary170,000 - 190,000 USD per year
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Job Details
- Experience
- 8+ years of Quality Assurance, Quality Systems, or Quality Management experience within the pharmaceutical, biotechnology, or life sciences industry
- Required Skills
- GCP
Requirements
- Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
- 8+ years of Quality Assurance, Quality Systems, or Quality Management experience in the pharmaceutical, biotechnology, or life sciences industry.
- Demonstrated experience managing electronic Quality Management Systems (eQMS), including administering or supporting platforms such as Dot Compliance, Veeva Quality, MasterControl, TrackWise Digital, or ComplianceWire.
- Working knowledge of FDA, EMA, ICH, GCP, GMP, and GLP requirements.
- Experience supporting regulatory inspections and external or internal audits.
- Ability to manage simultaneous priorities and changing deadlines.
- Strong analytical, organizational, and project management skills.
- Proficiency in MS Word and PowerPoint; experience with Adobe Acrobat Professional.
- Preferred: Direct administrator experience with Veeva Quality.
- Preferred: Experience with computerized system validation (CSV) and 21 CFR Part 11 compliance.
- Preferred: Experience supporting development-stage and commercial pharmaceutical operations and implementing or enhancing eQMS platforms.
- Must be able to travel as necessary.
Responsibilities
- Serve as the eQMS subject matter expert and administrator, evaluating proposed changes and coordinating testing, validation, and deployment.
- Integrate new business processes, departments, and vendors into the Quality Management System.
- Oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
- Maintain procedures, work instructions, validation documentation, and configuration records.
- Administer the training program, including role-based eQMS training, user support, and a centralized library of user guidance, job aids, and FAQs.
- Provide oversight and support for document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
- Manage vendor governance activities and periodic performance reviews, ensuring reviews are documented and filed.
- Maintain inspection readiness and support regulatory inspections and audits with records, reports, metrics, and system demonstrations.
- Present quality-system performance trends and recommendations to Quality leadership and lead or support continuous improvement initiatives.
- Collaborate across departments to standardize quality processes and monitor industry trends and regulatory expectations.
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