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QA Manager

3 months ago

Raleigh, United States Catalyst Clinical Research LLC Full time
Job DescriptionJob Description

 Position Summary:  As a QA Manager you will be responsible for the maintenance of a framework of compliant, systems and processes. You will work closely with the QA Director to support the Quality Management framework and a cycle of continuous improvement activities.  You will provide real-time advice to the Development Operations team.  As part of the role you will conduct internal audits, vendor audits, and will support sponsor audits of Catalyst.

Position Accountabilities/Responsibilities:

  • Serve as an expert in the interpretation and application of GCP regulatory requirements and expectations.
  • Support the maintenance and further development of Catalyst’s quality infrastructure, processes and systems to support compliance (including but not limited to regulatory compliance) of all projects.
  • Develop and maintain Standard Operating Procedures (SOPs), quality processes documentation, guidelines and support continual process improvements projects, as required.
  • Ensure implementation of training and effective communication of processes, to maintain knowledge and compliance. Develop and deliver relevant quality training across the business as required.
  • Manage the implementation of the Catalyst Quality Plan and audit program (internal and external) and lead internal and external audits as required.
  • Proactively drive improved efficiency and effectiveness by embedding learning from previous projects.
  • Review clinical documents (e.g., protocols, clinical study reports, informed consent forms, etc.) for compliance with regulations, regulatory guidelines, and SOPs.
  • Review quality data and develop analytics that can be used to identify trends.
  • Provide real-time support, guidance, and oversight for clinical studies with focus on GCP compliance. Resolve ad hoc quality issues.
  • Provides support for Issue and Event Management Activities (e.g., SOP Deviation and CAPA), perform root cause analysis, and manage related actions plans until resolution and closure. Verify that appropriate actions have been implemented, documented, and tracked.
  • Stay current on regulatory landscape and requirements. As new regulations and guidelines are released, inform relevant personnel as to the changes and determine the impact to procedures, staff, and systems.
Position Qualifications and Requirements: 
Education: 
  • A minimum of a Bachelor’s Degree in chemistry, biology, pharmacy, or related scientific field.  Advanced degree desirable but not required.
Experience: 
  • At least 7 years of experience in a GCP regulated environment that should include 3 years in Quality Assurance as a minimum. CRO experience is desirable but is not a requirement.
  • Proven relevant quality management experience ideally in a clinical background.
  • Excellent understanding of ICH GCP and Data Protection Regulation
  • Significant audit experience
  • Robust knowledge of delivery of complex activities around governance, compliance and risk management
  • Broad understanding of commercial drivers of the business
Required Skills:  
  • Strong verbal and written communication skills and an ability to present and influence credibly and effectively at all levels of the organization
  • Ability to articulate quality management and risk management concepts to all levels within the company
  • Versatility, flexibility, and a willingness to work within constantly changing priorities.
  • Proven ability to handle multiple projects and meet deadlines.
  • Excellent interpersonal, negotiation and conflict resolution skills
  • Strong verbal and written communication skills and an ability to present and influence credibly and effectively at all levels of the organization
  • Proven ability to manage multiple projects at a time while paying strict attention to detail
  • Working knowledge of MS office suite and able to generate business correspondence, create forms and generate reports as required
  • Demonstrated ability to work collaboratively with teams

Working Conditions:  ​​Sedentary work that primarily involves sitting/standing​.
 

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