The Sr. Manager, Quality Validation is responsible for developing validation strategy for Indivior and third-party manufacturing, packaging and testing. This role ensures compliance with regulatory requirements, industry standards, and develops company policies for validation of equipment, utilities, processes, computer systems, cleaning, and facilities.
Requirements
- 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
Benefits
- 3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st
- 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
- U.S. Employee Stock Purchase Plan- 15% Discount
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health, Dependent Care and Limited Purpose Flex Spending and HSA options
- Adoption assistance
- Tuition reimbursement
- Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
- Gym, fitness facility and cell phone discounts
