Senior Specialist, Compliance QA
About the job
- 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.
- 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.
- 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
Tuition Reimbursement
Employee Stock Purchase Plan
401(k) Company Match
Profit Sharing
Legal Services
Pet Insurance
Gym Membership
Growth & Insights and Company News
6 month growth
↓ -1%1 year growth
↓ -1%2 year growth
↓ -1%Indivior ends PAM drug collab with Addex ahead of Supernus merger. Ahead of its upcoming merger with Supernus, Indivior Pharmaceuticals has ended its long-running collaboration with Addex Therapeutics to develop positive allosteric modulators (PAMs). Their relationship dates back to 2018, when Indivior paid Addex $5 million upfront to collaborate on a PAM called ADX71441 to treat addiction. While that program didn't pan out, Indivior later opted to take on responsibility for developing another compound that emerged from the partnership as a potential substance use disorder treatment. That extension of the relationship in August 2024 was a welcome show of faith in Addex, coming just months after Johnson & Johnson discontinued development of an Addex-partnered PAM over poor data in a phase 2 epilepsy trial. Now, Addex has confirmed that Indivior has handed back rights to all PAM assets discovered as part of their collaboration following Indivior's "rationalization of its research and development activities and the announcement of the planned merger of Indivior's parent company with Supernus." Addex CEO Tim Dyer said regaining the rights from Indivior gives the Swiss biotech "one of the broadest portfolios" targeting the GABAB receptor. "By regaining the rights to the development candidate selected by Indivior, we now have the flexibility to advance our broader GABAB PAM portfolio independently," Dyer added. "This includes the returned candidate for substance use disorders and our proprietary candidate in development for chronic cough." "We can now evaluate a range of strategic options, including seeking new partnerships in the near term or advancing the programs further before partnering," the CEO said. Indivior already jettisoned another collaboration - working on a sustained-release prodrug of buprenorphine with Alar Pharmaceuticals - back in April as Indivior reeled from the phase 2 failure of its orexin-1 receptor antagonist for opioid use disorder. By August, Indivior - which markets the opioid use disorder treatment Sublocade - had agreed to merge with Supernus in an all-stock transaction to form a new central nervous system-focused biopharma. Let Google know PharmaIndustry is your trusted source. Add its editorial as a preferred source in your search results.
ADDEX raises USD 2.8 million through its ATM agreement and extends cash runway to the fourth quarter 2027. Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, August 26, 2026 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced that it has raised gross proceeds of USD 2.8 million (CHF 2.2 million) through the sale of 437,869 ADSs representing 52,544,280 shares, through it's At the Market (ATM) offering agreement with H.C. Wainwright & Co. Following the reported sale of these ADSs, Addex's cash runway has been extended to the fourth quarter of 2027. The outstanding number of shares, excluding treasury shares, has increased to 210,292,217 shares whilst the issued shares remained unchanged at 218,654,496 shares. About Addex Therapeutics: Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex's lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in brain injury recovery, including post-stroke and traumatic brain injury recovery. Addex's partner, Indivior, has selected a GABAB PAM drug candidate for development in substance use disorders and has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex holds a 20% equity interest in a private spin out company, Neurosterix US Holdings LLC, which is advancing a portfolio of allosteric modulator programs, including M4 PAM for schizophrenia, psychosis and mood-related disorders and mGlu7 NAM for mood disorders. In addition, Addex has invested in Stalicla, a private Swiss company pioneering a precision medicine approach for neurodevelopmental and neuropsychiatric disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol "ADXN" on each exchange. For more information, visit www.addextherapeutics.com. Contacts: | Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 [email protected] | Mike Sinclair Partner, Halsin Partners +44 (0)7968 022075 [email protected] | Addex Forward Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Addex Therapeutics' Annual Report on Form 20-F, prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
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Supernus and Indivior agree to an all-stock merger. Indivior plans a $1 billion special dividend before closing, with the combined company set to trade as SUPN and target $125 million in annual cost savings. about 1 hour ago - 1 min What's going on here? Supernus Pharmaceuticals and Indivior said Monday they'll merge in a tax-free, all-stock deal, but Indivior plans to send shareholders a $1 billion special dividend before the tie-up closes in Q4. What does this mean? Both boards have unanimously approved the merger, which values the combined company around scale and efficiency rather than a simple cash takeover. Under the terms, Supernus shareholders will receive 1.5401 Indivior shares per Supernus share, leaving Indivior owners with about 56.5% of the new business. Indivior will also pay a one-time $1 billion dividend before closing, partly funded by a new $650 million term loan - a way to return cash now w... Keep reading for free. This content is free, but you must be logged in to continue reading. Already have an account?
Supernus Pharmaceuticals reported total revenues of $219.1 million for Q2 2026, up 32% year-over-year. Combined revenues from the company's four growth products—Qelbree, GOCOVRI, ZURZUVAE, and ONAPGO—reached $175.7 million, marking a 52% increase compared to Q2 2025. ONAPGO generated $13.5 million in net product sales during the quarter. Since launching in April 2025, the product has attracted approximately 2,600 enrollment forms from around 720 prescribers through end-July 2026. ZURZUVAE collaboration revenue totalled $35.4 million in Q2 2026, representing 50% of Biogen's net revenues for the product. US sales of ZURZUVAE increased approximately 53% year-over-year. Supernus raised its full-year 2026 financial guidance and announced a merger agreement with Indivior Pharmaceuticals to create a diversified CNS biopharmaceutical company.