Senior Quality Assurance Manager

About the Role

Our client is seeking a highly experienced and detail-oriented Senior Quality Assurance Manager to oversee quality systems and ensure compliance within their pharmaceutical operations. This fully remote role is crucial for maintaining the highest standards of quality and regulatory adherence across all aspects of the business, from product development to manufacturing and distribution. You will lead QA initiatives, conduct internal audits, and work collaboratively with various departments to implement and improve quality processes. This is an excellent opportunity for a dedicated QA professional to drive quality excellence in a dynamic, remote-first pharmaceutical environment.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with GxP guidelines.
• Lead internal and external audits, ensuring compliance with regulatory requirements and identifying areas for improvement.
• Oversee the investigation of quality deviations, CAPAs, and change controls, ensuring timely and effective resolution.
• Provide QA support for product development, manufacturing, and validation activities.
• Train and mentor QA staff and other personnel on quality systems and regulatory compliance requirements.

Requirements

• Bachelor's degree in a scientific, technical, or related field; advanced degree preferred.
• Minimum of 8 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of GxP regulations (GMP, GCP, GLP) and quality management principles.
• Proven experience in developing and implementing QMS, conducting audits, and managing deviations.
• Strong analytical, problem-solving, and leadership skills, with excellent written and verbal communication capabilities for remote collaboration.

Benefits

• Competitive salary and performance-based incentive programs.
• Comprehensive health, dental, and vision insurance coverage.
• Generous paid time off and company holidays.
• Opportunities for professional growth, certifications, and further education.
• A supportive and fully remote working culture, promoting work-life balance and flexibility.