Senior Manager, Quality Assurance

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

📋 Description

• Oversee quality assurance and compliance efforts within your area, ensuring your team meets the highest standards.

• Create and implement quality assurance strategies and procedures to facilitate clinical trial operations.

• Perform thorough quality assessments and audits to guarantee adherence to regulatory standards and guidelines.

• Work collaboratively with cross-functional teams to identify and resolve quality-related issues, implementing corrective measures as necessary.

• Engage in the evaluation and approval of clinical trial documentation and data to ensure precision and completeness.

• Offer leadership and mentorship to quality assurance personnel, promoting a culture of excellence and ongoing improvement.

⛳️ Requirements

• Bachelor's degree in a relevant field.

• At least 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO sector, including a minimum of 3 years in a management or leadership position.

• Comprehensive understanding of regulatory requirements and guidelines pertaining to clinical trials (e.g., ICH-GCP, FDA regulations).

• Strong analytical and problem-solving capabilities, with the skill to identify and address complex quality challenges.

• Outstanding communication and interpersonal abilities, enabling effective collaboration with colleagues and stakeholders at all levels.

• Willingness to travel as necessary (approximately 35%).

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.