What are the responsibilities and job description for the Quality Specialist position at Osprey Life Sciences?
Quality Lead / Specialist
A World Class Company
Osprey is a consulting, software development and services firm specializing in the delivery and support of IT processes and solutions across the life sciences product development and delivery life cycle. We focus on ensuring that our client’s mission critical information technology initiatives result in a substantive business outcome, through a distinctive combination of technical and business acumen.
Role requires onsite in Boston, MA.
The Role :
We are seeking a highly skilled and experienced Quality Lead to join our reputable pharmaceutical company. As the Quality Lead, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards throughout our organization. You will play a crucial role in the development and implementation of quality systems, processes, and procedures.
You Will :
- Develop and maintain the Quality Management System (QMS) in compliance with applicable regulations, standards, and guidelines, such as FDA, GMP, and ICH.
- Oversee and lead the quality assurance and quality control activities, ensuring compliance with established procedures and specifications.
- Conduct internal audits and inspections to identify areas for improvement and ensure adherence to quality standards. Coordinate with cross-functional teams to address any non-conformances and implement corrective and preventive actions (CAPAs).
- Establish and maintain key performance indicators (KPIs) to monitor the effectiveness of the quality systems and processes. Analyze data trends and provide recommendations for continuous improvement.
- Collaborate with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure quality considerations are integrated into all stages of the product lifecycle.
- Participate in external audits and regulatory inspections, ensuring readiness and compliance. Address audit observations and implement appropriate corrective actions.
- Provide guidance and training to employees on quality-related topics, ensuring awareness and adherence to quality policies, procedures, and regulations.
- Stay updated on industry trends, regulatory changes, and best practices related to quality management in the pharmaceutical industry. Recommend and implement changes to maintain compliance and improve overall quality performance.
- Drive a culture of quality excellence and continuous improvement throughout the organization by promoting quality awareness, engaging employees, and fostering a proactive approach to quality assurance.
You Bring :
We offer an excellent compensation and benefits package and an opportunity to learn, grow and contribute to a stimulating, fast-paced environment where individual contributions are recognized and rewarded.
Osprey is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.