INACTIVE
Senior Specialist, Compliance QA
$88k - $108k
Senior
Bachelor's
Raleigh, NC, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A bachelor's degree in life sciences, engineering, or a related technical discipline from an accredited university is required.
- At least five years of GMP/GXP pharmaceutical experience is required.
- In-depth knowledge of current GMP/GXP and FDA trends and guidelines is required.
- Experience authoring Annual Product Reviews is required.
- Experience conducting internal audits is required; Certified Quality Auditor certification is preferred.
- Technical writing skills and technical reviewer experience are required.
- Ability to communicate effectively verbally and in writing with employees at all levels on compliance matters is required.
- In-depth knowledge of quality assurance terminology, methods, and compliance tools is required.
- Computer skills are required.
- Ability to manage multiple tasks and redirect focus in response to company needs is required.
- Ability to adapt to schedule changes, shifting priorities, and cross-functional task alignment is required.
- Proficiency in problem-solving and risk mitigation is required.
- Travel of less than 10% is required.
- Employees must demonstrate unquestionable ethics and integrity, know and adhere to policies applicable to their role, and raise concerns about potential violations or unethical behavior.
Responsibilities
- Develop, implement, and maintain systems and procedures to support inspection readiness and regulatory compliance.
- Participate in multifunctional project teams as a Quality Compliance representative when directed by the CQA Manager or Site Quality Director.
- Develop and drive compliance initiatives based on new regulations, guidance documents, industry standards, and applicable global procedures.
- Function as a change controller and CAPA manager for site records.
- Facilitate data compilation and author Annual Product Review reports.
- Author Quality Agreements.
- Create the self-inspection schedule, perform self-inspections, write audit reports, and follow up on observations and non-conformances.
- Participate in customer and regulatory audits as required.
- Review and approve GMP documents, including procedures, validation protocols, engineering documents, and critical work orders.
- Coordinate vendor-initiated changes and vendor complaints.
- Compile and report site compliance metrics.
- Perform quality assurance review and approval of incoming materials in the ERP system as required.
- Provide support and guidance to ensure Good Documentation Practices are applied throughout the Raleigh site.
- Track deviations, environmental excursions, out-of-specification investigations, CAPAs, and change controls in the electronic quality management system through closure, and design and implement action plans to meet procedural requirements.
- Perform laboratory data review as needed.
- Distribute components, raw materials, and bulk product.
- Release systems for use.
- Perform other assigned duties and responsibilities.
Desired Qualifications
- Experience with Veeva is preferred.
- Experience reviewing laboratory data and audit trail data is preferred.
About the company
Indivior focuses on developing medicines for substance use disorders and serious mental illnesses. Its products are prescription pharmaceutical treatments, brought to market after research and development, and sold through healthcare professionals to patients worldwide. The company’s approach centers on patient safety, with ongoing monitoring and reporting of adverse events to ensure high-quality therapies. Compared with competitors, Indivior emphasizes targeted medicines for addiction and mental health, combining scientific R&D with a global commercialization presence to address critical healthcare needs. Its goal is to create sustainable value by improving patient outcomes and addressing unmet medical needs in global health.
Company Size
501-1,000
Company Stage
IPO
Headquarters
Bon Air, Virginia
Founded
2014
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Simplify's Take
What believers are saying
- Q1 2026 revenue rose 19% to $317 million, driven by SUBLOCADE's 32% growth.
- Indivior raised 2026 guidance to $1.215-$1.285 billion and EBITDA to $620-$660 million.
- The $1 billion special dividend and $125 million synergies signal disciplined capital returns and cost cuts.
What critics are saying
- Indivior ended its Addex PAM collaboration on September 25, 2026, shrinking pipeline optionality.
- Management killed INDV-6001 and INDV-2000 in 2026, exposing thin internal pipeline execution.
- SUBLOCADE concentration makes any payer squeeze, safety event, or generic threat existential.
What makes Indivior unique
- SUBLOCADE dominates long-acting buprenorphine, with over 500,000 patients prescribed by Q1 2026.
- Indivior owns a rare addiction-focused commercial platform with global reimbursement and prescriber relationships.
- The Supernus merger creates a broader CNS franchise with 11 marketed medicines and $2.2 billion revenue.
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Benefits
- Paid Vacation
- Paid Holidays
- Paid Sick Leave
- Flexible Work Hours
- Remote Work Options
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Health Savings Account/Flexible Spending Account
- Adoption Assistance
INACTIVE