VP, Quality

VERO BIOTECH INC•Atlanta, GA

6d•Onsite

About The Position

The VP, Quality provides strategic leadership and oversight for the organization’s Quality function, including Quality Assurance, Quality Control, Quality Compliance, Validation, and Supplier Quality. The role ensures the effectiveness of the Quality Management System (QMS), compliance with applicable regulatory requirements and industry standards, and a culture of quality throughout the organization. The position leads and develops the quality team, establishes quality objectives, and partners cross-functionally to support operational excellence, regulatory readiness, and continuous improvement. The VP directs the Quality function, manages its budget and workflows, and serves as the company’s designated Management Representative for quality and compliance matters. The position also leads audits and inspections and oversees the documentation, testing, validation, and data-review activities needed to maintain quality and regulatory compliance.

Requirements

Ph.D. or M.S. in a related field and at least 5 years of relevant experience, or a B.S. in a related field and at least 10 years of relevant experience.
Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product and process validation.
Thorough understanding of GMP regulations, the Code of Federal Regulations (CFR), and factors affecting regulatory compliance.
Knowledge of and ability to apply statistical methods to evaluate and interpret data.
Thorough knowledge of FDA regulations and quality system requirements.
Experience working in a laboratory environment, including familiarity with laboratory equipment and safety procedures.
Experience in research and development, including a strong understanding of statistical analysis.
Demonstrated ability to lead, supervise, and motivate team members.
Commitment to excellence, continuous improvement, and high-quality standards.
Strong organizational, analytical, problem-solving, and decision-making skills.
Ability to manage multiple priorities and workflows effectively.
Exceptional attention to detail and accuracy.
Demonstrated ability to plan, organize, and execute complex projects.
Ability to work independently and collaboratively on cross-functional teams and committees.
Proven ability to manage multiple projects simultaneously and meet established deadlines.
Working knowledge of data collection, data analysis, data evaluation, and the scientific method.
Strong verbal and written communication skills, including the ability to prepare clear, concise, and timely reports and presentations.

Responsibilities

Direct and oversee all Quality functions in alignment with organizational goals and objectives.
Maintain and monitor the effectiveness of the Quality Management System and ensure quality requirements are met and appropriately reported.
Assess processes and procedures, identify improvement opportunities, and implement solutions to improve quality performance.
Develop, implement, and sustain quality systems and controls in accordance with GxP requirements, including GMP, GLP, and GCP, and company SOPs.
Author, review, and approve protocols, reports, SOPs, product specifications, and batch records.
Ensure ongoing compliance with current Good Manufacturing Practices and applicable regulatory requirements.
Oversee product testing and analysis for compliance with cGMP regulations, SOPs, and quality standards.
Identify technical and quality-related challenges and drive corrective and preventive solutions.
Lead review of data supporting method validations and stability studies, ensuring technical reports and summaries are accurate and reliable.
Ensure timely completion and maintenance of documentation supporting testing and validation activities.
Develop, manage, and maintain the departmental budget.
Lead internal, supplier, and regulatory GMP audits and inspections.
Recruit, train, mentor, and develop Quality personnel; manage departmental workflows and resource allocation.
Assign responsibilities, monitor work quality, and ensure adherence to company policies, procedures, and regulatory requirements.
Provide day-to-day leadership, coaching, and performance management for direct reports and team members.
Monitor departmental activities, identify issues proactively, and implement corrective actions as needed.
Demonstrate organizational leadership through communication, transparency, integrity, strategic thinking, and development of high-performing teams.
Create and implement development plans to support employee growth and succession planning.
Serve as the company’s designated Management Representative for quality and compliance matters.
Perform other duties and responsibilities as assigned.