Description

Position Summary

 

The VP, Quality is responsible for providing strategic leadership and oversight for all aspects of the organization's Quality function, including Quality Assurance, Quality Control, Quality Compliance, Validation, and Supplier Quality. This role ensures the effectiveness of the Quality Management System (QMS), drives compliance with applicable regulatory requirements and industry standards, and promotes a culture of quality throughout the organization. The Vice President of Quality leads and develops the quality team, establishes quality objectives, and partners cross-functionally to support operational excellence, regulatory readiness, and continuous improvement initiatives.

 

 

Essential Duties and Responsibilities

• Direct and oversee all Quality functions to ensure alignment with organizational goals and objectives.

• Maintain and monitor the effectiveness of the Quality Management System (QMS), ensuring all quality requirements are met and appropriately reported.

• Assess existing processes and procedures, identify opportunities for improvement, and implement effective solutions to enhance quality performance.

• Develop, implement, and sustain quality systems and controls in accordance with GxP requirements (GMP, GLP, and GCP) and company Standard Operating Procedures (SOPs).

• Author, review, and approve protocols, reports, SOPs, product specifications, and batch records.

• Ensure ongoing compliance with current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements.

• Oversee product testing and analysis activities to ensure compliance with cGMP regulations, SOPs, and quality standards.

• Identify technical and quality-related challenges and drive effective corrective and preventive solutions.

• Provide leadership and accountability for the review of data supporting method validations and stability studies, ensuring the accuracy and integrity of technical reports and summaries.

• Ensure the 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 while managing 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.

• Maintain visibility into departmental activities, proactively identifying issues and implementing corrective actions as needed.

• Demonstrate organizational leadership through effective communication, transparency, integrity, strategic thinking, and the 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.

Qualifications

• Ph.D. or M.S. in a related field with a minimum of 5 years of relevant experience, or a B.S. in a related field with a minimum of 10 years of relevant experience.

• Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, Good Manufacturing Practices (GMPs), and product and process validation.

• Thorough understanding of GMP regulations, the Code of Federal Regulations (CFR), and factors impacting regulatory compliance.

• Knowledge of and ability to apply statistical methods in the evaluation and interpretation of 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 effectively manage multiple priorities and workflows.Exceptional attention to detail and accuracy. 

• Demonstrated ability to plan, organize, and execute complex projects.

• Ability to work independently and collaboratively as a member of 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, with the ability to prepare clear, concise, and timely reports and presentations.