Website Opiant Pharmaceuticals

Clinical Quality Manager (GCP)

This position is based in the United Kingdom

Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and overdose. We are a publicly traded company, listed on the NASDAQ exchange under the ticker symbol OPNT. At Opiant, we envision a world where addictions are recognized as diseases of the brain and treated like other chronic medical conditions. We are applying science and technology to address some of the most serious conditions affecting our communities, including opioid overdose and opioid use disorder; acute cannabinoid overdose; and alcohol use disorder. We aspire to be the leading life science company in this field of healthcare. For more information visit: www.opiant.com.

Job purpose:

Your primary responsibility will assist in the definition, implementation and maintenance of the Quality Management System (QMS) in conjunction with company policies, global & local regulatory requirements and ICH GCP / GxP standards.

Your key responsibilities:

  • Ensure compliance, drive consistency and support to improve and standardize the key operational activities with quality processes, standards and outcomes
  • Actively communicate and collaborate with functional areas to develop strong working relationships and provide the project quality support
  • Cooperate with Clinical Operations and Project Management teams to provide the quality support and help resolve audit findings and quality issues
  • Promote quality approach cross-functional teams in a matrix system
  • Identify the potential challenges, propose solutions and advocate the proactive engagement
  • Support the audits and perform TMF quality control (focusing on completeness, accuracy, timeliness)
  • Create and maintain strong data alignment between internal and external sources of quality data
  • Identify compliance gaps and make recommendations for the quality programs and continuous improvement initiatives
  • Create and review assigned Standard Operating Procedures (SOPs) in conjunction with the relevant regulations and standards
  • Carry out the assignments to the standards of high quality, efficiency, innovation, accuracy, integrity and safety in accordance with company and regulatory requirements
  • Conduct additional activities as assigned

What you’ll bring to the role:

  • At least 5 years’ experience in the quality (auditing, quality oversight, QMS) working in Pharmaceutical, Biotechnology and/or CRO company
  • Bachelor’s degree in Pharmaceutical or Science discipline as a minimum
  • Strong knowledge of QMS complexity with a practical understanding of global and local requirements and ICH GCP / GxP standards
  • Demonstrated ability to work independently and to drive the completion of tasks
  • Proven track record of delivering continual process improvement in systems and processes
  • Experience in internal, external and/or system auditing would be an advantage
  • Strong logical and analytical thinking skills
  • Ability to learn from and support others overcome obstacles
  • Excellent communication, problem-solving, presentation and interpersonal skills

Opiant offers attractive and competitive benefits, exciting development opportunities and a great atmosphere. You will be part of an enthusiastic, dedicated and highly motivated team.

EEO Statement:

Opiant Pharmaceuticals is an Equal Opportunity Employer and we take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Commitment to Diversity & Inclusion:

Opiant embraces diversity, equal opportunity, and inclusion. We support employees who are in recovery from substance use disorders. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace where we work to the following ‘O-P-I-A-N-T’ standards: open-minded, professional, innovative, accountable, nimble and trustworthy.

Apply for job

To apply for this job email your details to jedwards@opiant.com