Sr. Manager, Quality Validation

Role Summary

Sr. Manager, Quality Validation responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing. This role ensures compliance with regulatory requirements and industry standards, and develops policies for validation of equipment, utilities, processes, computer systems, cleaning, and facilities. Acts as the validation SME within Indivior and partners with site validation teams to provide strategy and execution as needed.

Responsibilities

• Develop, implement and maintain the Indivior validation policy and validation master plan
• Lead validation activities for process validation, sterile manufacturing, oral solid dose, utilities, and computer systems
• Oversee validation activities at third party CMOs/CMOs to ensure compliance with internal and regulatory requirements
• Author, execute, review and approve validation protocols, summary reports and supporting documentation
• Ensure validation activities meet Annex 1, FDA, EMA and ICH requirements
• Maintain validation systems in compliance with cGMPs and global regulations
• Support regulatory inspections, audits, and due diligence reviews as the SME for validation
• Partner with CMOs to ensure validation programs are robust and compliant
• Collaborate cross functionally with Quality, Manufacturing, Regulatory and IT teams to align validation strategies with Indivior goals
• Implement risk-based validation approach as applicable to improve efficiency
• Identify and drive opportunities for system and process improvements
• Ensure validation documentation provided by third party suppliers complies with all required Indivior and Regulatory standards
• Lead or support the development of User Requirement Specifications (URSs)
• Lead or support factory acceptance tests and site acceptance tests, review protocol, approve protocol, participate in FAT/SAT execution, review and approval FAT/SAT final report
• Lead or support risk assessments associated with validation equipment and process validation activities
• Support engineering studies led by the Technical Operations/Engineering Teams/CMC internally and externally with CMOs/CMOs
• Support regulatory updates to the regulatory dossier pertaining to validation
• Ensure annual validation and requalification activities are performed internally and externally
• Lead or support Installation Qualification/Operational Qualification/Performance Qualification and Process Validation activities
• Maintain the Indivior Validation Policy, internal validation master plans, validation SOPs, and work instructions
• Demonstrate strong technical understanding of GxP pharmaceutical equipment, facilities and processes
• Demonstrate strong root cause analysis skills for authoring deviations and identifying necessary CAPAs
• Exhibit strong leadership and communication to facilitate investigations across functions and meet timelines
• Drive completion of deviations and ensure CAPA effectiveness
• Provide input to project teams supporting new product launches and product development through validation
• Participate in Continuous Improvement activities including procedural enhancements for North America commercial activities
• Develop and carry out training programs with Global Quality Management and OPEX to relay policies and local QMS requirements
• Other duties as determined to support North America Quality team
• Some US and international travel required (approximately 10%)

Qualifications

• Minimum ten (10) years of pharmaceutical manufacturing or quality with at least eight (8) years in validation, executing and leading validation teams in a regulated industry
• Bachelor‚Äôs degree in Engineering, Life Sciences or related field required (Master‚Äôs degree preferred)
• Direct experience in root cause analysis (RCA) and critical thinking
• Strong sterile and microbiological experience
• Strong understanding of small molecule products
• Broad knowledge of current GMPs and regulatory requirements (EU, Health Canada, TGA, ICH, PIC/S, ISO, etc.)
• Results oriented, entrepreneurial, with strong planning, organizational abilities, and risk evaluation capabilities
• Strong analytical skills and ability to translate strategy into actionable plans
• Strong leadership, communication and listening skills; excellent presentation, written and oral communication
• Proven ability to work under pressure without compromising deliverables
• Data analysis and trend interpretation skills for quality system performance
• Strong computer and technical skills including Microsoft suite, SAP, Kaye, VEEVA, AI, and familiarity with validation equipment and related systems

Skills

• Validation strategy development
• Risk-based validation
• Regulatory compliance (FDA/EMA/ICH/etc.)
• Root cause analysis and CAPA management
• Cross-functional collaboration
• Project leadership and vendor management
• Technical writing (URS, protocols, reports)
• Training program development
• Data analysis and trend assessment

Education

• Bachelor‚Äôs degree in Engineering, Life Sciences or related field required; Master‚Äôs degree preferred

Additional Requirements

• Travel: Less than 10% travel