Indivior

Sr. Specialist, Compliance QA

Raleigh, NC · Senior

Sponsorship not specified$88k-$108kDetected 16 days ago

ERPGMPFDA RegulatoryProblem SolvingWritingAdaptabilityGxP

About the role

Distribution of components, raw materials, and bulk product
Participate in multi-functional project teams as a Quality Compliance representative as directed by the CQA Manager or Site Quality Director.
Function as a change controller and CAPA manager for site records.

Develop, implement, and maintain systems and procedures to ensure a high level of inspection readiness and regulatory compliance.
Develop and drive compliance initiatives based on new regulations, guidance documents, industry standards, and Indivior global procedures as they apply to the site.
Create the self-inspection schedule, perform self-inspections, write audit reports, and follow up on observations and non-conformances.
Participate in the review and approval of GMP documents including, but not limited to procedures, validation protocols, engineering documents and critical work orders.
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD).
Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category.

Participate in customer and regulatory audits, as required.
Perform QA review and approval of incoming materials in the ERP System, as required.
Bachelor's Degree in life sciences, engineering, or a related technical discipline from an accredited university required.
Minimum five (5) years GMP/GXP Pharmaceutical experience required.
Must have an in-depth knowledge of current GMP/GXP as well as FDA trends and guidelines.
Must have excellent technical writing skills and technical reviewer experience.
Must be able to communicate effectively both verbally and in writing with all levels of employees on all aspects of compliance.
Must be organized, detailed, and have ability to handle multiple tasks at once and redirect focus based on company's needs.
In-depth knowledge of quality assurance terminology, methods, and compliance tools.
Must be adaptable to schedule changes, shifts in priority and cross-functional task alignment.

Must have experience conducting internal audits, Certified Quality Auditor preferred.
Computer skills required
experience with Veeva preferred.
Experience reviewing lab data and audit trail data preferred.

Eligible to receive a yearly grant as part of Indivior's Long-Term Incentive Plan
Facilitate the compilation of data and author the Annual Product Review reports.

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.
Eligible to participate in Indivior's bonus program, based on company and individual performance
Competitive PTO plus company closure from December 24th- January 1st
401(k) and Profit-Sharing Plan- Company match
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
Tuition reimbursement

Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.
Specialist supports the Quality and Compliance systems at the Raleigh facility.
This role is primarily responsible for authoring Annual Product Reviews (APRs), conducting site self-inspections, management of Change Control and CAPA records, and authoring of Quality Agreements.
Specialist will have a high level of interaction and influence within the site and is expected to drive improvements to the systems for which the role is responsible.
Less than 10% travel.
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:
Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company.
The following benefits are provided by Indivior, subject to eligibility requirements.
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.

EOE/Minorities/Females/Vet/Disabled are encouraged to apply!
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined.
The employee may perform other functions that may be assigned.
Management retains the discretion to add or change the duties of this position at any time.

This listing is sourced directly from Indivior's careers page and normalized into a canonical job model.