Indivior
Overview
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Indivior is headquartered in Richmond, VA, and employs approximately 500 people globally.
Location: Richmond, VA
Position Summary The Global Quality Systems and Operational Excellence (OPEX) Manager is a key member of the global quality organization, responsible for establishing and maintaining Quality Systems and driving a culture of quality. The role focuses on creating strategic plans with cross-functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System (PQS). The manager will support review and approval of GxP IT system change controls and validation documents, lead the product quality complaints process, and facilitate global deviation and CAPA management to support the business.
Essential Functions
Influence cross-functionally to create strategic plans for the establishment and lifecycle management of a compliant PQS with over 100 cross-functional processes.
Oversee and action GxP IT system change controls and validation documents; support technical transfer, testing, qualification and validation.
Write, review and/or approve validation protocols and reports.
Provide GxP IT support to INDIVIOR in reviewing and approving IT change controls, quality assurance plans and validation records.
Participate in 3rd party validation planning meetings and communicate key information to stakeholders.
Lead management and triage of product quality complaints.
Identify and report process and IT system metrics to drive compliance; interpret metrics to identify areas for improvement.
Provide direct assistance to Quality Operations for resolution of quality events.
Act as a process owner for Quality Management System processes.
Act as IT system Superuser and support IT system changes, executing test scripts when required.
Ensure compliance and reduced regulatory risk in the PQS.
Ensure PQS processes enable commercial product release across markets globally.
Provide oversight and influence for PQS processes and work with stakeholders to rectify compliance gaps.
Utilize continuous improvement methodologies (Lean Six-Sigma) and project management to improve processes; support related CI activities.
Support IT change management and validation activities that may impact product and/or process.
Support GxP changes and updates to SOPs, Work Instructions, specifications, and controlled documents.
Monitor process health via metrics and ensure training for involved personnel; update documentation as processes change.
Provide training support for new and existing employees as needed.
Participate in regulatory inspections and readiness efforts.
Perform other duties as determined by management to support the Quality Systems and OPEX team.
Minimum Qualifications
Bachelor of Science degree in a relevant scientific discipline from an accredited university required.
Proven track record, minimum eight (8) years of quality experience in a regulated industry (FDA regulated, pharmaceutical or medical device).
Broad knowledge of GMPs and regulatory requirements (GAMP5, EU, Health Canada, TGA, ICH, PIC/S).
Knowledge of sterile manufacturing.
Proficient in validation and qualification, risk assessments for equipment, facility and process.
Results-oriented, entrepreneurial, self-motivated with strong planning and organizational capabilities; able to evaluate risks and make judgments on risks to mitigate.
Strong analytical skills with the ability to develop tactics and measurable implementation plans.
Excellent communication skills (presentation, written and oral).
Ability to work under pressure while maintaining deliverables.
Ability to collect, understand, interpret and trend data on quality system performance.
Advanced computer skills including Microsoft Office and Visio.
Competencies/Conduct
Proficient in risk assessments to support deviation investigations, change management and CAPA.
Skilled at training and coaching others in problem solving and root cause analysis.
Advanced working knowledge of electronic quality systems (e.g., Veeva, SAP, SuccessFactors) is an advantage.
Excellent team player with strong interpersonal and communication skills.
Ability to influence without direct authority, including senior management.
Logical, process-based thinking suitable for a global role; travel as required.
Lean Six-Sigma Green Belt certification is preferred.
Benefits
3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24 to January 1.
401(k) with company match on contributions and profit sharing plan.
Employee Stock Purchase Plan with discount.
Comprehensive medical, dental, vision, life and disability coverage.
Flexible spending accounts and HSA options.
Adoption assistance, tuition reimbursement, and concierge/personal assistance services.
Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage.
Gym and fitness facility discounts.
Guiding Principles and Compliance Indivior’s guiding principles guide each employee’s performance. Employees are expected to demonstrate understanding and adherence in daily work. Indivior is committed to compliance and encourages speaking up about potential policy violations or unethical behavior. Employee and manager obligations include ethics, risk awareness, and fostering a Speak Up culture, with ongoing review and mitigation.
Position Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
Equal Employment Opportunity (EEO): EOE/Minorities/Females/Vet/Disabled
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Location: Richmond, VA
Position Summary The Global Quality Systems and Operational Excellence (OPEX) Manager is a key member of the global quality organization, responsible for establishing and maintaining Quality Systems and driving a culture of quality. The role focuses on creating strategic plans with cross-functional stakeholders to improve compliance and reduce risk in the Pharmaceutical Quality System (PQS). The manager will support review and approval of GxP IT system change controls and validation documents, lead the product quality complaints process, and facilitate global deviation and CAPA management to support the business.
Essential Functions
Influence cross-functionally to create strategic plans for the establishment and lifecycle management of a compliant PQS with over 100 cross-functional processes.
Oversee and action GxP IT system change controls and validation documents; support technical transfer, testing, qualification and validation.
Write, review and/or approve validation protocols and reports.
Provide GxP IT support to INDIVIOR in reviewing and approving IT change controls, quality assurance plans and validation records.
Participate in 3rd party validation planning meetings and communicate key information to stakeholders.
Lead management and triage of product quality complaints.
Identify and report process and IT system metrics to drive compliance; interpret metrics to identify areas for improvement.
Provide direct assistance to Quality Operations for resolution of quality events.
Act as a process owner for Quality Management System processes.
Act as IT system Superuser and support IT system changes, executing test scripts when required.
Ensure compliance and reduced regulatory risk in the PQS.
Ensure PQS processes enable commercial product release across markets globally.
Provide oversight and influence for PQS processes and work with stakeholders to rectify compliance gaps.
Utilize continuous improvement methodologies (Lean Six-Sigma) and project management to improve processes; support related CI activities.
Support IT change management and validation activities that may impact product and/or process.
Support GxP changes and updates to SOPs, Work Instructions, specifications, and controlled documents.
Monitor process health via metrics and ensure training for involved personnel; update documentation as processes change.
Provide training support for new and existing employees as needed.
Participate in regulatory inspections and readiness efforts.
Perform other duties as determined by management to support the Quality Systems and OPEX team.
Minimum Qualifications
Bachelor of Science degree in a relevant scientific discipline from an accredited university required.
Proven track record, minimum eight (8) years of quality experience in a regulated industry (FDA regulated, pharmaceutical or medical device).
Broad knowledge of GMPs and regulatory requirements (GAMP5, EU, Health Canada, TGA, ICH, PIC/S).
Knowledge of sterile manufacturing.
Proficient in validation and qualification, risk assessments for equipment, facility and process.
Results-oriented, entrepreneurial, self-motivated with strong planning and organizational capabilities; able to evaluate risks and make judgments on risks to mitigate.
Strong analytical skills with the ability to develop tactics and measurable implementation plans.
Excellent communication skills (presentation, written and oral).
Ability to work under pressure while maintaining deliverables.
Ability to collect, understand, interpret and trend data on quality system performance.
Advanced computer skills including Microsoft Office and Visio.
Competencies/Conduct
Proficient in risk assessments to support deviation investigations, change management and CAPA.
Skilled at training and coaching others in problem solving and root cause analysis.
Advanced working knowledge of electronic quality systems (e.g., Veeva, SAP, SuccessFactors) is an advantage.
Excellent team player with strong interpersonal and communication skills.
Ability to influence without direct authority, including senior management.
Logical, process-based thinking suitable for a global role; travel as required.
Lean Six-Sigma Green Belt certification is preferred.
Benefits
3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24 to January 1.
401(k) with company match on contributions and profit sharing plan.
Employee Stock Purchase Plan with discount.
Comprehensive medical, dental, vision, life and disability coverage.
Flexible spending accounts and HSA options.
Adoption assistance, tuition reimbursement, and concierge/personal assistance services.
Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage.
Gym and fitness facility discounts.
Guiding Principles and Compliance Indivior’s guiding principles guide each employee’s performance. Employees are expected to demonstrate understanding and adherence in daily work. Indivior is committed to compliance and encourages speaking up about potential policy violations or unethical behavior. Employee and manager obligations include ethics, risk awareness, and fostering a Speak Up culture, with ongoing review and mitigation.
Position Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
Equal Employment Opportunity (EEO): EOE/Minorities/Females/Vet/Disabled
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