Global Quality Systems Leader

3 weeks ago

Slough, Slough, United Kingdom Indivior Full time

POSITION SUMMARY:

The role of Global Quality Systems Manager is integral to the global quality framework at Indivior, focusing on fostering a robust 'culture of quality'. This hands-on position reports directly to the Head of Quality Systems & Operational Excellence (OPEX) and is tasked with overseeing, ensuring compliance, and enhancing specific components of Indivior's Global Pharmaceutical Quality System.

KEY RESPONSIBILITIES:

The responsibilities of this position encompass, but are not limited to, the following:

  • Serve as a champion for the development and lifecycle management of the Indivior Pharmaceutical Quality System (PQS).
  • Ensure quality processes are effective, facilitating the release of commercial products that support patient markets worldwide.
  • Engage in a global capacity across all functions with GxP responsibilities, with travel expected as necessary.
  • Implement continuous improvement methodologies throughout Supply & QA, including Lean Six-Sigma practices and project management.

General Quality System & OPEX Responsibilities:

  • Collaborate with the QS & OPEX team to ensure the PQS is well-designed, standardized, simplified, enhanced, and communicated in compliance with all relevant international regulations and standards.
  • Identify and communicate relevant process and IT system metrics to functional leaders to drive compliance and improvement.
  • Act as process owner for designated processes, ensuring oversight and compliance.
  • Address product and process quality issues and associated risks with the Quality Leadership Team (QLT) and Senior Leadership Team (SLT) as necessary.
  • Maintain the PQS Portal and participate in regulatory inspections and readiness efforts.
  • Collaborate with GxP functions to implement enhancements across the PQS.
  • Identify process improvements based on root cause analysis and data-driven evidence, utilizing Lean Six-Sigma methodologies.
  • Provide leadership and influence to functional management to promote OPEX initiatives.
  • Deliver relevant updates to Heads of functions regarding OPEX status.

Process Owner Responsibilities:

  • Monitor and enhance the execution of processes through metrics and control measures, ensuring documentation is updated and personnel are adequately trained.
  • Act as an IT system Superuser, supporting and advising on system changes and executing test scripts as required.

Global Training Process Owner:

  • Oversee process design and IT systems to ensure compliance and user engagement.
  • Support the IT system's use in collaboration with the IT function.
  • Engage with partner groups to design and maintain training matrices.
  • Establish and report appropriate metrics for GxP training to drive compliance.
  • Ensure Supply/QA curricula are relevant and accurate, meeting system metric targets.
  • Work with SLT & QLT to identify training gaps and develop mitigation plans.
  • Create core GxP training packages with subject matter experts and consultants.
  • Lead Global Employee Onboarding to GxP Systems.

Global Document Management Process Owner:

  • Manage the process and IT system to ensure compliance and user engagement.
  • Ensure SOPs and instructional documents are clear, logically structured, and easily identifiable for training audiences.
  • Maintain compliance status for SOPs and instruction documents within the system.
  • Supervise the use of the IT system and business management.
  • Ensure training and access governance for the document system is established and maintained.
  • Deliver training for authors and approvers to new users and provide regular refresher training.
  • Organize drafts and final copies of SOPs and QA-controlled documents for easy retrieval with restricted access.
  • Oversee the periodic review process for Commercial QA and Supply documents.
  • Manage DocuSign IT system business oversight as a global Superuser.
  • Lead GxP record retention and archiving processes globally.

Regulatory Intelligence:

  • Support the Process Owner in ensuring key regulatory changes are communicated and integrated into the PQS for ongoing improvement.
  • Align with Regulatory Affairs to leverage resources for effective communication and information sharing.

MINIMUM QUALIFICATIONS:

  • Bachelor's degree in a life science or engineering field is preferred.
  • Experience in establishing quality processes and systems within the pharmaceutical, biopharma, or medical device sectors.
  • Strong working knowledge of continuous improvement tools and techniques.
  • Project Management experience or certification is advantageous.
  • Green Belt Certification in Lean Six-Sigma is preferred.
  • Intermediate to advanced understanding of drug product/device regulatory requirements (e.g., EU GMP, WHO, PIC/S, CFR Part 4, CFR 21 Part 210/211/820).
  • Proficient in training and coaching others in problem-solving and root cause analysis.
  • Familiarity with electronic Quality systems used at Indivior (e.g., TrackWise, SuccessFactors, Veeva) is a plus.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the candidate will demonstrate:

  • Strong interpersonal and communication skills, with the ability to convey information clearly to peers and senior management.
  • Capability to deliver concise summaries to senior management.
  • Effective presentation and update delivery skills.
  • Influencing skills in areas without direct reporting authority.
  • Logical, process-oriented thinking essential for effective role performance.
  • Adeptness in understanding diverse perspectives to achieve optimal outcomes for the global business.
  • Strong planning and organizational abilities.
  • Ability to identify effective cross-functional solutions considering business objectives, quality, cost implications, and organizational maturity.

BENEFITS:

Indivior is dedicated to fostering a culture guided by core principles and providing exceptional benefits that reflect the significance of our work. The Indivior experience includes:

  • Three weeks of vacation, along with floating holidays and sick leave.
  • 401(k) and Profit Sharing Plan with a company match of 75% on the first 6% of contributions, plus a profit-sharing contribution equal to 4% of eligible pay.
  • U.S. Employee Stock Purchase Plan with a 15% discount.
  • Comprehensive Medical, Dental, Vision, Life, and Disability coverage.
  • Health and Dependent Care Flexible Spending options.
  • Adoption assistance.
  • Tuition reimbursement.
  • Access to concierge/personal assistance services.
  • Voluntary benefits, including Legal, Pet Insurance, and Auto/Home coverage.
  • Discounts on gym memberships, fitness facilities, and cell phone plans.
  • A culture unified by our Guiding Principles, Core Values, and Vision.

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