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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 Head 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:

           Create and revise GCP compliant Clinical Research SOPs through the Change Control process

           Participate in the revision of overarching QMS SOPs to ensure adherence to GCP

           Train GxP staff on pertinent SOPs

           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 and that required clinical site audits are conducted as appropriate

           Manage clinical CAPA and assist clinical study teams or functional groups with implementation of corrective actions as appropriate

           Develop and interpret GCP audit findings (resulting from internal and/or external audits) across the organization in order to communicate trends and provide recommendations to address such developing trends in a proactive manner

           Assist in the development of, 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

           Stay abreast of any updates to applicable GCP regulations and guidance update and retrain Clinical Research personal to the changed regulations as appropriate

           Identify, recommend and support management in process improvement initiatives

           Maintain close contact with industry/professional organizations to be aware of trends and initiatives in quality assurance, GCP compliance, and inspections

           While maintaining independence, work closely with other QA colleagues to assure common understanding of developing interpretations of GXP System

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 combination of education and experience

           Advanced computer skills in MS Excel and Word

           Demonstrated ability to problem-solve and implement improvements to enhance efficiency

           Extremely detail-oriented

           Excellent verbal and written communication skills

           Excellent interpersonal skills; mature with a proven ability to work well with others throughout a diverse organization

           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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