General Job Description/Team Overview:
This position is responsible for providing quality oversight and design control best practices for the Research and Development and Process Development laboratories. The specialist will work closely with R&D, PD, and QA to recommend and lead the implementation of quality initiatives to ensure compliance with regulatory requirements and guidance, including but not limited to Good Laboratory Practices (GLP).
Primary Duties and Responsibilities (include but are not limited to):
• Establish and maintain R&D, PD quality systems, policies, and procedures for oversight of GVO’s development programs/operations.
• Ensure implementation of a risk-biased approach to regulatory compliance as it relates to research, laboratory, and development activities.
• Conduct internal and external laboratory audits to ensure compliance with established procedures and quality system processes.
• Manage deviations and regulatory non-compliance related to development laboratory and functional areas impacting R&D and PD including reporting on investigations, impact, and resolution to Senior Management.
• Review and approve GLP related documents associated with the development, laboratory operations, and quality systems such as training, document control, protocols, reports, notebooks, etc.
• Provide GLP training and oversight for R&D and PD groups and programs.
• Represent Quality in cross-functional development teams in the safe and compliant execution of projects necessary to achieve departmental and company goals.
• Observe GLP operations and provide appreciative and constructive feedback to staff and mangers.
• Support the laboratory vendor selection process and vendor qualifying program as it relates to function areas supporting R&D and PD.
• Identify and make recommendations for improvements and work on problems of a diverse scope where analysis and problem-solving is required.
• Participate on various CMC related project teams.
• Alert management of significant quality, compliance, supply, and safety risks.
• Perform other duties as assigned.
• Bachelor’s degree in a scientific or technical discipline and 5 years of Quality experience in the regulated pharmaceutical/biotech industry.
• Demonstrated in-depth experience of establishing and operating development quality systems in the biotech industry.
• Practical experience in applying GLPs; comprehension of quality and GLP principles; experience in administration and/or development of quality systems for R&D and PD operations.
• Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change.
• Ability to handle multiple simultaneous priorities in a high-volume work environment; ability to manage several tasks simultaneously.
• Ability to resolve conflict with tact and diplomacy.
• Strong attention to detail; highly organized.
• Sound decision-making, technical and problem-solving skills; demonstrate initiative.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement. • Good work ethic, dependable, punctual, and flexible; great leader and team player with a can-do attitude.
• Must exhibit professional integrity and maturity with high degree of discretion dealing with confidential information.
• Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.
• Excellent organizational skills with attention to detail and accurate recordkeeping.
• General knowledge of Federal and State regulatory requirements in a GxP environment.
• Excellent written, verbal, and interpersonal communication skills.
• Ability and willingness to work flexible hours when needed.
• Eligible to work in the U.S.
Job Type: Full-time
If you're interested in joining our Team, start by applying here and attaching your resume.