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Arbutus Biopharma

Manager, Clinical Quality Assurance

Quality – Warminster, Pennsylvania
Department Quality
Employment Type Regular Full-Time
Minimum Experience Experienced

 About us:

At Arbutus we have a vision: to cure chronic Hepatitis B virus (HBV).  We have a dedicated and innovative team and we are uniquely positioned to transform the HBV treatment landscape.  We are developing a portfolio of drug candidates with multiple mechanisms of action that we believe will result in a combination therapy to cure HBV.

If you are looking to join a team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you.

 

Role Summary:

The Manager, Clinical Quality Assurance is accountable to the Director of Quality Assurance for QA oversight of clinical trials conducted with Arbutus investigational products in line with corporate and project objectives, and in accordance with all appropriate regulatory, scientific and corporate standards.

 

Duties and responsibilities: 

  • Conduct clinical GCP vendor audits, clinical site audits and GCP internal process audits
  • In conjunction with the Clinical Research department develop a yearly audit plan to ensure continuing clinical vendor oversight
  • Manage clinical CAPAs and assist clinical study teams / functional groups with implementation of corrective actions 
  • Create and revise GCP Clinical Research SOPs and overarching QMS SOPs to ensure compliance
  • Stay abreast of updates to applicable regulations, update relevant procedures and train staff
  • Develop and interpret GCP audit findings (from internal /external audits and industry trends), communicate trends and provide recommendations to ensure proactive compliance
  • Assist in the development and yearly review of the Clinical Quality Management plan
  • Act as a member of Clinical Study Teams
  • Conduct quality reviews of Clinical Study documents (e.g., protocol, Investigator’s Brochure, informed consent forms)
  • Assist in the User Acceptance Testing of clinical databases
  • Identify, recommend and support management in process improvement initiatives
  • Assist with additional Quality activities, as needed


Requirements/Qualifications:

  • Bachelor's or Master’s degree in a Life Sciences discipline, with at least 5 years of experience in a Clinical QA role or equivalent
  • Experience as a lead external auditor
  • Knowledge of current GCP regulatory requirements
  • Proficient in MS Outlook, Excel and Word
  • Demonstrated ability to problem-solve and implement improvements to enhance efficiency
  • Detail-oriented and excellent verbal and written communication skills
  • Excellent interpersonal skills, with a proven ability to work well with others in a diverse organization
  • Ability to travel (Domestic / International)
  • Ability to manage deadlines and prioritize effectively, while maintaining flexibility
  • Ability to demonstrate creativity, work independently, and take initiative


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        • Location
          Warminster, Pennsylvania
        • Department
          Quality
        • Employment Type
          Regular Full-Time
        • Minimum Experience
          Experienced
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