POSITION SUMMARY:
The Global Quality Systems Manager role is a key part of the global quality organisation in helping to establish and drive a ‘culture of quality’ at INDIVIOR. This is a tactical, hands-on role, reporting to the Head of Quality Systems & Operational Excellence (OPEX). This position will be responsible for the management, compliance and improvement of specified elements of INDIVIOR’s Global Pharmaceutical Quality System.
ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:
1. Champion for the establishment and lifecycle management of the INDIVIOR Pharmaceutical Quality System (PQS).
2. Quality processes are effective, enabling commercial product release supporting patient’s markets supplied globally.
3. Global role that works across all functions where there is GxP responsibility. Expected to travel to meet the needs of the role.
4. Continuous improvement methodology and deployment across the Supply & QA. This includes Lean Six-Sigma Methodologies and project management.
General Quality System & OPEX Responsibilities:
5. Working as part of the QS & OPEX team, ensure that the PQS is effectively designed, standardised, simplified, improved and communicated to follow all applicable international regulations and standards, where product is manufactured and distributed.
6. Identify and report appropriate process & IT system metrics and trends to functional heads to drive compliance. Able to interpret metrics and trends and based on this, identify areas of improvement.
7. Act as process owners for your named processes (see section on specific accountabilities).
8. Provide direct oversight for the PQS processes (where the QS & OPEX does not have Process Ownership) and work with stakeholders to identify compliance gaps and identify improvements.
9. Escalate product and process quality issues and identified risks to the QLT and SLT teams as appropriate
10. Ensure that the PQS Portal is maintained.
11. Participating in key regulatory inspections and readiness efforts internally and externally as needed.
12. Partner with GxP functions organisation to implement improvements across the PQS.
13. Identification of improvements to the GxP processes based on root cause analysis, data driven evidence and use of appropriate Lean Six-Sigma methodology and tools.
14. Provide thought leadership and influence functional management to Champion OPEX within their functions.
15. Provide relevant information to the Heads of functions about the status of OPEX in their functions.
General Process Owner Responsibilities include:
16. Monitor and improve the health and execution of your process through metrics (process & IT system metrics) and other appropriate control measures, update the documentation periodically or as the process changes and ensure the relevant people are adequately trained for their role the process
17. Act as IT system Superuser (if the process uses an IT system) and able to support and advise on IT system changes and carryout execution of test scripts when required.
Global Training Process Owner:
18. Manage the process design and IT system to ensure compliance and engage the users.
19. Superuser supporting the use of the IT system, in conjunction with the IT function.
20. Engage partner groups in support of training matrices design and maintenance.
21. Determine, establish and report appropriate metrics for GxP training, such that metrics drive compliance to the process.
22. Ensure that Supply/ QA curricula is relevant to the individual and accurate and system metric targets are being met.
23. Work with SLT & QLT to identify gaps in training and develop plans to mitigate.
24. Develop core GxP packages with SMEs and consultants (where necessary) and train out.
25. Act as a Supply consultant to enable development of better training packages such that they are tailored to the audience and contain the relevant technical details for the roles.
26. Lead (or support where needed) Global Employee Onboarding to GxP Systems.
Global Document Management Process Owner:
27. Manage the process and IT system to ensure compliance and engage the users.
28. Ensure that the SOPs and instruction documents are authored in accordance with best practice to be clear with regards to responsibilities, logical process flow and training audience can be easily identified.
29. Ensure that SOPs and instruction documents and loaded into the correct area and maintain the continued compliance status for the system.
30. Superuser supporting the use of the IT system and business management.
31. Ensure training and access governance for document system is in place and maintained.
32. Authors and approver training is delivered to new users and refresher training delivered on a regular basis.
33. Ensure that the drafts, working and final copies of SOPs, and other QA controlled documents are organised into electronic files and are easily retrievable when required and that these files have restricted access.
34. Manage the periodic review process for Commercial QA and Supply organisation documents such as policies, SOPs and other controlled documents.
35. DocuSign IT system business management and oversight, global Superuser.
36. Lead oversight for GxP record retention and archive processes globally.
Regulatory Intelligence:
37. Support the Process Owner to: Ensure that key changes in regulations and standards are effectively communicated and incorporated into the PQS for continual improvement. Align with Regulatory Affairs to leverage existing resources for the same efforts to maximise efforts and share information.
MINIMUM QUALIFICATIONS:
38. Bachelor of Science degree in a life science or engineering (preferred)
39. Experience in establishing quality processes and systems in the pharmaceutical, biopharma or medical device industries.
40. Excellent working knowledge of CI tools and techniques.
41. Project Management experience or certification.
42. Green Belt Certified in Lean Six-Sigma
43. Intermediate to advanced level of practical understanding of drug product/ device regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR Part 4, CFR 21 Part 210/211/820).
44. Highly skilled at training and coaching others in problem solving, root cause analysis, and execution of improvements.
45. In-depth working knowledge of the electronic Quality systems used at Indivior is an advantage (e.g. TrackWise, SuccessFactors, Veeva)
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
46. Strong interpersonal and communication skills and ability to communicate clearly to peers and senior management is an advantage.
47. Able to deliver concise written or oral summaries to senior management
48. Ability to deliver effective presentations and updates is an advantage
49. Influencing skills in areas with no direct reporting authority
50. Logical, process based thinking necessary to work effectively in role.
51. Able to understand different perspectives and deliver the best outcome for the global business.
52. Strong planning and organisation skills
53. Must be able to identify effective cross-functional solutions through understanding of the business objectives, quality, cost implications, and organizational maturity.
BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
54. 3 weeks’ vacation plus floating holidays and sick leave
55. 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
56. U.S. Employee Stock Purchase Plan- 15% Discount
57. Comprehensive Medical, Dental, Vision, Life and Disability coverage
58. Health and Dependent Care Flex Spending options
59. Adoption assistance
60. Tuition reimbursement
61. Leverage Concierge/personal assistance services
62. Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
63. Gym, fitness facility and cell phone discounts
64. Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.