Overview
Quality Control Manager Jobs in United States at E Logic
Piper Companies is seeking an Associate Director of Quality Operations for a fully remote position. The Associate Director of Quality Operations will manage QA project management for pre-clinical and clinical programs, providing GXP support to Clinical, CMC, and non-clinical teams. This role includes managing documentation review, compliance trending, quality issues, and vendor oversight. The Associate Director will develop and maintain the Quality Management System (QMS) and lead GXP risk assessment activities to ensure compliance with global regulatory and internal quality systems requirements.
Responsibilities of the Associate Director of Quality Operations include:
Provide GXP QA oversight, including risk assessments, quality initiatives, and compliance with study protocols, SOPs, and regulatory requirements.
Collaborate with external vendors and internal teams to ensure project objectives are met in a compliant and timely manner.
Develop and implement GXP audit programs and manage Significant Quality Issues, including root cause analysis and remediation.
Oversee GXP document management and training via Veeva Vault, and promote quality culture and data integrity.
Lead GXP PAI readiness activities, establish and track site GXP quality metrics, and contribute to Quality Management Review and Quality Council processes.
Qualifications for the Assistant Director include:
Minimum of 10 years in biotech or pharma, particularly in biologics/gene therapy.
Extensive experience in quality assurance, clinical research, GCP, GMP, and QA compliance, with knowledge of pre-clinical and clinical development programs and quality management systems.
Proven ability to manage multiple projects in a dynamic environment, demonstrating self-motivation, resourcefulness, and attention to detail.
Strong written and verbal communication skills, with the ability to work collaboratively and independently in both remote and onsite environments, and a hands-on approach with cross-functional capabilities.
Preferred CQA Certification and experience with VeevaVault, along with knowledge of FDA regulations, ICH standards, and other regulatory requirements.
Bachelor’s Degree in life sciences is required, preferably with experience in AAV Gene Therapy.
Compensation for the Assistant Director:
Annual Salary Range: $120,000-$200,000
Comprehensive Benefits: Bonus: 10-15% based on title, unlimited PTO, sick leave if required by law, 12-13 paid holidays, equity based on title, 401K with match, medical, dental, and vision coverage.
This job opens for applications on 3/4/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Job Id:
137496
Job Category:
Job Location:
Remote
Security Clearance:
No Clearance
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Madalyn Barry
Title: Quality Control Manager
Company: E Logic
Location: United States
