Sr. Manager, Quality Validation

Role Summary

Sr. Manager, Quality Validation. Location: Richmond, VA. Responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing. Serves as the validation SME within Indivior and collaborates with local site validation teams to provide strategy and execution to maintain product quality, patient safety, and regulatory compliance.

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 CMO/CPO to ensure compliance with internal and regulatory requirements
• Author, execute, review and approve validation protocols, summary report 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 that 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 w/CMOs/CPOs
• Support any regulatory requests pertaining to updates to the regulatory dossier associated with validation
• Ensure annual validation and requalification activities are performed internally and externally
• Lead or support Installation Qualification/Operational Qualification/Performance Qualification and Process Validation (PV) activities
• Maintain the Indivior Validation Policy, internal validation master plans (VMPs), validation standard operating procedures (SOPs), work instructions (WI)
• Must have strong technical understanding of GxP pharmaceutical equipment, facilities and processes
• Must have strong root cause analysis skills for authoring deviations and identifying the necessary CAPAs
• Must have strong leadership and communication and able to facilitate investigations across multiple functions and complete within the required timelines
• Drives completion of deviations and ensures CAPA have been implemented and monitored for effectiveness to ensure Indivior has a quality centric continuously improving business
• Participates in and provide quality input to project teams supporting new product launches
• Participates in New and Existing Product development through the technical transfer and validation process
• Participates in Continuous Improvement activities including procedural enhancements to support the commercial activities in North America
• In conjunction with Global Quality Management and the OPEX team, develops and carries out training programs to ensure relevant Indivior policies/procedures and local QMS requirements are relayed to appropriate staff
• Any other duties as determined by management to support North America Quality team
• Some US and International travel required (approximately 10%) to support vendor relations, audit program and work with the global quality team

Qualifications

• Bachelor‚Äôs degree in Engineering, Life Sciences or related field in a relevant scientific discipline from an accredited university required (Master‚Äôs degree preferred)
• 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 such as FDA, pharmaceutical or medical device
• 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, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S, ISO, etc.
• Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action
• Strong Leadership, communication and listening skills
• Excellent communication skills - presentation, written and oral
• Proven ability to work under pressure without compromising deliverables
• Collects, understands, interprets, and trends data on quality system performance
• Strong computer and technical skills including Microsoft platform, SAP, Kaye, VEEVA, AI, validation equipment i.e. Kaye Validator, Val Probes, ellabs, thermocouples, building management (BMS) systems, equipment HMI, filling equipment, autoclaves, HVACs, CTUs, portable monitoring devices, etc.

Additional Requirements

• TRAVEL: Less than 10% travel.