Senior Quality Systems Lead – Hybrid/Remote

Apr; United States; Vor Ort; USD 140.000 - 200.000; Vollzeit

Zusammenfassung

Apr is seeking a Senior Manager of Quality Systems to lead and optimize quality processes in a hybrid environment based in Redwood City, CA, with remote options, on a 12-month contract that can be renewed.

The role requires deep GMP and QA knowledge, CAPA and deviation management, and strong collaboration across functions to ensure compliant, efficient QMS execution and audit readiness.

Qualifikationen

• Bachelor’s degree in a scientific or technical field; equivalent experience considered.
• 10+ years of pharma/biotech Quality Assurance or Quality Systems experience.
• Strong background with deviations, investigations, CAPAs, and quality events.
• Solid knowledge of GMP, Quality Risk Management, and data integrity.
• Experience with eQMS platforms, audits/inspections, and quality metrics.
• Strong communication and cross-functional collaboration skills.
• Advanced degree or relevant Quality certification a plus.
• Commercial-stage pharma/biotech experience a plus.

Aufgaben

• Lead training, coaching, and guidance on Quality Events, QMS processes, and regulatory expectations.
• Serve as SME and backup reviewer/approver for deviations and other Quality Events.
• Support complaint and excursion investigations, plus CAPA development, implementation, and effectiveness checks.
• Drive audit and inspection readiness through complete, accurate, timely documentation.
• Support QMS process improvement, metrics, and trending.
• Partner cross-functionally to resolve quality issues and strengthen QMS execution.

Kenntnisse

Quality leadership

QA oversight

Cross-functional collaboration

Regulatory awareness

Ausbildung

Bachelor's degree in science/engineering

Advanced degree / cert (quality)

Tools

eQMS platforms

Jobbeschreibung

Apr is seeking a Senior Manager of Quality Systems to lead and optimize quality processes in a hybrid environment based in Redwood City, CA, with remote options, on a 12-month contract that can be renewed.

The role requires deep GMP and QA knowledge, CAPA and deviation management, and strong collaboration across functions to ensure compliant, efficient QMS execution and audit readiness.