Job Overview
We invite you to join a pioneering organization dedicated to enhancing the health and quality of life for millions affected by chronic respiratory diseases. As we expand our commitment, following the recent FDA approval of our first product for chronic obstructive pulmonary disease (COPD), we seek to develop innovative treatments for a variety of respiratory conditions. This is your… opportunity to make a significant impact on patient care and advance your career within a forward-thinking company.
Key Responsibilities
• Lead the Quality Assurance (QA) function across all Good Practice (GxP) areas, ensuring compliance and excellence.
• Oversee the management and professional development of the QA team, fostering a culture of continuous improvement.
• Develop, implement, and maintain the Quality Management System (QMS) strategy and procedures to ensure adherence to regulatory requirements.
• Assess organizational competencies, identify areas for enhancement, and advocate for necessary resources.
• Mentor and guide QA team members to elevate their skills and performance.
• Execute an audit and compliance program, conducting audits for GxP vendors, investigator sites, and internal departments.
• Collaborate with cross-functional teams to support ongoing quality improvement initiatives.
• Ensure readiness for inspections and participate actively in regulatory inspections.
• Evaluate and implement GxP computer systems to align with business priorities, confirming proper validation processes.
• Manage the QA function’s budget while undertaking additional responsibilities as required.
Required Skills
• Extensive knowledge of GxP regulations (GMP, GCP, etc.) and their practical applications.
• Strong leadership abilities with a proven track record in mentoring high-performing teams.
• Excellent verbal and written communication skills, adept at presenting complex information to senior stakeholders.
• Exceptional problem-solving capabilities and the ability to balance multiple priorities in a dynamic environment.
• Strong strategic and critical thinking skills, with the ability to influence across various functions.
Qualifications
• Bachelor’s degree in Life Sciences or a related field.
• Over 17 years of progressive compliance experience in quality management roles within the pharmaceutical or biotech sectors, with expertise across multiple GxP areas.
• Demonstrated experience in preparing for and leading health authority inspections.
• Comprehensive understanding of quality risk assessment methodologies and their successful application.
Career Growth Opportunities
Joining our team means accessing substantial opportunities for professional development within the QA function. We are committed to nurturing talent and promoting a culture of continuous improvement and excellence in quality assurance practices.
Company Culture And Values
We pride ourselves on maintaining a diverse and inclusive work environment where innovation thrives. Our commitment to patient care and progress in drug development encourages every team member to contribute to shaping a brighter future for individuals facing chronic respiratory diseases.
Networking And Professional Opportunities
By becoming part of our organization, you will gain access to extensive professional networking opportunities and collaborative projects, enabling you to enhance your skills and build impactful connections within the healthcare industry.
Employment Type: Full-Time
Company: Get It Recruit – Executive
Location: Anywhere
Salary Range:
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