Quality Operations Lead

TITLE:

Title: Quality Operations Lead

Reports To: Head of Quality Operations – North America

Location: Richmond, VA

POSITION SUMMARY:

This role is responsible to support Quality Operations in the US and Most of World for all Indivior Products.

The Quality Operations Lead role is intended to support Quality Operations across all areas of Supply from Manufacturing, Packaging, Logistics for all Indivior Products.  Quality Operations will ensure products are manufactured and packaged in full compliance with cGMP and regulatory requirements and supporting on-time delivery of patient supply to stakeholders in the US and Most of World.

The scope of this role will also ensure compliance through maintenance of quality technical agreements, providing inspection/audit support, updating SOPs and work instructions, review and approval of product quality complaints, review of temperature excursions, lead and manage change controls, lead and execute CAPAs, execution change control action items, authoring deviations, and authoring risk assessments.  Batch record review for manufacturing and secondary packaging may be required as necessary.  If needed this role can also support commercial release for supply.  This role will also be responsible to support operations of third party vendors through Supplier Quality Oversight and maintenance of all purchase requisitions.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

• Understanding of all Indivior Products and their Supply Chain to enable Quality Operations support.
• Provide leadership, support and guidance to Indivior Quality Professionals in the US, EU, Canada, AuA and Most of World (MOW) to allow commercial release of Indivior Products.  This involves liaising with CMOs, CPOs, 3PL to obtain product information to support Qualified Persons (QP) and Responsible Persons (RP) certification and ensure commercial release of Indivior Products.
• Author and maintain Quality Technical Agreements between Indivior, intracompany functions, CMOs/CPOs/3PL, external partners, and suppliers.
• Manage and create all purchase requisitions/purchase orders and on time payment of invoices for all NAQA external vendors, test labs, service providers, and suppliers
• Provide direct support for all inspection and audit activities. Assist in managing inspection activities.
• Support and or author responses to audits, inspections or health authority queries
• Lead and author deviations and perform the impact assessment, root cause analysis, and identify CAPAs
• Lead and author risk assessments, perform the impact assessment, rate the severity, likelihood, probability, risk score, identify risk mitigation strategies, and determine overall risk and conclusion/path forward
• Lead and manage change controls and CAPAs
• Perform impact assessments on change controls
• Execute change control action items
• Author and/or review SOPs, work instructions, protocols or job aids
• Review and approve deviations, change controls and CAPAs in the Indivior QMS system
• Review temperature data and author/approve Product Disposition Statements for Temperature Excursions
• Participate and/or Present in JOT meetings for CMOs, CPOs, Suppliers and all other Third Party Partners.  The Quality Operations Lead is expected to create slides and collate data/KPIs, to present to evaluate performance and all other issues relevant to the discussion.
• Lead and manage continuous improvement activities and drive to completion
• Participate in the review, investigations and responses for product quality complaints.
• Review manufacturing and packaging batch records as required to support product disposition
• Assist in providing training support for new and existing employees. 

• Ensure that Annual Product Reviews have been completed by responsible parties and have been assessed internally against requirements and are delivered according to schedule.

• Any other duties as determined by management to support North America Quality Operations Team

MINIMUM QUALIFICATIONS:

License/Certifications: N/A

Travel:  Minimum 10%

• Bachelor of Science degree in a relevant scientific discipline from an accredited university required.
• Proven track record, minimum five (5) years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
• Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.
• Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks. Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated.
• Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
• Excellent communication skills - presentation, written and oral.
• Proven ability to work under pressure without compromising deliverables.
• Must be comfortable working in a team environment or working independently under minimal supervision.
• Collects, understands, interprets and trends data on the quality system performance.
• Strong computer skills including SAP, Veeva, TrackWise, Microsoft Office Suites, MS Project, MS Copilot, must be adept in learning and using new technology as it relates to the professional work environment

COMPETENCIES/CONDUCT:

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

• Adherence to Indivior Guiding Principles
• Adherence to the Indivior Code of Conduct