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QA Manager

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About the role

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QA Manager

 
Location: North Wales, PA
 
ICON Clinical Research has a strong reputation in our approaches to clinical development. As a Top 5 global Clinical Research Organization, we apply scientific and operational excellence across all phases of clinical trial outsourcing services for our clients.
 
At ICON we have an incredible opportunity for an expert QA manager to join the team in our North Wales, PA offices.
 
Are you ready to join an innovative and first class QA team?
 
Are you a strategic thinker and enjoy driving quality process improvements?
 
As QA manager, you will report directly to a QA Director. You will be responsible for partnering with business partners to build quality into IT systems and processes while enabling innovation, efficiency, and continuous improvement, adherence to the applicable regulations and patient safety. You will use your influencing skills to ensure we are aligned on priorities, and provide your expertise and problem solving skills as needed.
 
Day to day responsibilities will include:
  • Provide Quality validation leadership support as the Quality – IT liaison for computer system assessments, validation and change control, and provide effective Quality support at all applicable support points of the Software Development Lifecycle (SDLC).
  • Lead and perform quality assessments and vendor audits of IT vendors, to ensure quality oversight and routine periodic review of vendor compliance performance.
  • Contribute to the execution of configuration, validation, deployment and management of ICON IT System. Collaborating with Business Operations, IT and other partners to ensure effective delivery.
  • Perform timely and effective QA review of validation documentation such as SOPs, Master Validation Plans, Traceability Matrices, Testing deliverables, and Data Migration Plans.
  • Lead and coordinate efforts for the identification, development, implementation of IT programs, policies and procedures in support of ICON’s GXP programs as primary QA IT contact along with other Quality and cross-functional members
  • Actively provide suggestions for solutions to process issues, and collaborate with appropriate partners to drive efficiency.
  • Provide timely updates on projects and deliverables to Quality Management and any other functions that support IT validation project deliverables.
  • Provide GXP subject matter expertise as needed – perform critical assessments/data and document reviews, conduct audits, develop SOPs and role model investigation/problem solving skills.
  • Work in collaboration with Global Quality management to support IT audits (internal and external) to assure adherence to company SOPs, and any applicable regulatory requirements
  • Identify and demonstrate standard methodologies across the enterprise for ICON Quality Systems.
  • Contribute the ensuring effective budgetary control within the department.
To be successful you will need:
  • A minimum of 5 years QA (or equivalent) experience in the pharmaceutical or CRO industry, with some previous management/supervisor responsibilities preferred.
  • Bachelor’s Degree in related field is required while an advanced degree is preferred
  • In depth understanding of concepts, theories and principles in own discipline with some knowledge of other disciplines e.g. data management, biostatistics, business development, project management etc.
  • People management skills, you will enjoy guiding and developing your team.
  • Change management skills with the ability to secure staff dedication to change.
  • In depth knowledge and understanding of drug development and the clinical trial process
  • Highly developed problem solving skills, and the ability resolve difficult situations. Team building and leadership skills.
  • Demonstrated training skills, including the ability to give constructive feedback.
  • Ability to gain the confidence and cooperation of colleagues.
  • Cost consciousness, with good commercial awareness and customer focus.
  • Knowledge of regulations, hosting audits, preparing audit reports, corrective and preventative actions (CAPA) and complaint handling.
  • You will enjoy working cross functionally and a global level.
  • Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver’s license.
Benefits of Working in ICON
 
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a phenomenal career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
 
Other than working with a phenomenal team of switched on and ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
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