Senior Quality Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and oversee the Quality department, encompassing recruitment, training, and performance management.

• Ensure adherence to cGMP, FDA, EMA, ISO 13485, and other international regulatory standards.

• Supervise quality systems, including CAPA, deviations, change control, and document management.

• Serve as the primary quality liaison with CDMOs and testing laboratories.

• Promote inspection readiness and conduct internal audits.

• Review and authorize batch records, SOPs, change controls, methods, specifications, protocols, reports, and quality-related documentation.

• Collaborate with cross-functional teams to facilitate product development and commercialization.

• Oversee supplier quality and manage vendor qualification processes.

• Identify and execute continuous improvement initiatives within the quality system.

• Track key quality metrics and communicate trends to senior leadership.

• Ensure thorough investigation and resolution of quality issues and complaints.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related discipline (advanced degree preferred).

• 8–12+ years of experience in pharmaceutical/biotech QA roles, with leadership responsibilities.

• In-depth knowledge of cGMP regulations and global regulatory requirements.

• Demonstrated hands-on experience in managing quality systems (batch review, CAPA, deviations, change control).

• Strong analytical and problem-solving skills.

• Willingness to travel up to 10–20% as required.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Opportunities for professional development.