Support development and implementation of QA processes for clinical programs.
Serve as QA contact across clinical development, trial ops, pharmacovigilance, and data sciences.
Provide GCP compliance guidance and support audits.
Maintain data integrity and end-to-end quality oversight.
Identify opportunities for process improvements and CAPA.
Support inspection readiness and regulatory responses.

🎯 Requirements

BA/BS required; advanced degree a plus.
6-8 years in biopharma R&D with 3+ years in manager-level GCP QA.
Experience drafting, reviewing, implementing SOPs.
Knowledge of global GCP regulations; GVP a plus.
Experience with internal/external audits and CAPA.
Working knowledge of Veeva or similar QMS; inspection tools a plus.

🎁 Benefits

Career advancement opportunities
Competitive compensation and bonus
401K with employer contributions
Generous stock options and ESPP
Paid time off: 20 days + 18 holidays
Comprehensive benefits package

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