QA Validation Lead

Purpose

The ideal candidate will be responsible for overseeing all validation activities, ensuring compliance with regulatory requirements, and maintaining the highest standards of quality. This role requires extensive experience in validation processes, including equipment, process, and facility validation and is crucial for maintaining the integrity and quality of pharmaceutical products, ensuring they meet all regulatory and safety standards.

Main Responsibilities

•    Leadership: Lead and manage the validation team to ensure all validation activities are conducted in compliance with regulatory requirements and industry standards. Provide leadership and guidance on validation-related issues, including troubleshooting and problem-solving.
•    Documentation: Develop, implement, and maintain validation protocols and procedures for equipment, processes, and facilities. Ensure timely and accurate documentation of all validation activities and results. Prepare and present validation reports to senior management and regulatory authorities.
•    Qualification: Oversee the execution of validation studies, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
•    Issue Resolution: Investigate validation and qualification failures, and deviations, ensure timely and effective resolution, and implement corrective and preventive actions. 
•    Risk Assessments:  Conduct risk assessments and develop mitigation strategies for validation-related issues.
•    Collaboration: Collaborate with cross-functional teams, including quality assurance, manufacturing, and engineering, to support validation efforts.
•    Continuous Improvement: Ensure continuous improvement of validation processes and procedures. Design and execute initiatives to enhance compliance, efficiency, and cost-effectiveness. 
•    Regulatory Compliance: Ensure the validation and qualification activities and documentation is suitable for regulatory inspections. 
•    Budget Management: Prepare and manage the site quality budget for validation activities, ensuring expenditures align with projections.
•    Resource Management: Ensure adequate resources, including manpower, to maintain compliance with GxP requirements for validation and qualification activities.
•    Governance: Prepare and present validation strategies to Chiesi senior management
•    Development: Stay current with industry trends and regulatory changes to ensure the site remains compliant with all applicable requirements.
 

Experience Required

•    Minimum of 10 years of experience in pharmaceutical quality assurance, with at least 5 years in a leadership role.
•    Extensive experience in validation and qualification processes, including equipment, process, and facility validation.
•    In-depth knowledge of regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GMP) and quality systems.
 

Education

Bachelor’s or Master’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or related field. Advanced degree preferred.

Languages

•    Fluent in English spoken language 
•    Proven ability to write clear, concise, and grammatically correct content in English

Skills & Abilities

•    Excellent project management and organizational skills.
•    Exceptional communication, problem-solving skills and decision-making abilities, with the ability to collaborate effectively with cross-functional teams.
•    Strong leadership and management skills, with the ability to effectively lead and motivate a team.
•    Ability to work cross-functionally and build strong relationships with diverse teams.

Soft Skills