Sr. Manager, Quality Validation

* 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
* Ensures 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
* Bachelor’s degree in Engineering, Life Sciences or related field in a relevant scientific discipline from an accredited university required (Master’s 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,…