Quality Assurance Lead

1 week ago

Cork, Cork, Ireland beBeeValidation Full time

Job Title: Quality Assurance Validation Manager

 

Our organization seeks a seasoned Quality Assurance Validation Manager to lead the development and execution of comprehensive validation processes, ensuring adherence to relevant regulations and standards. This role will oversee compliance with software and hardware validation regulatory requirements.

 

Key Responsibilities:

  • Develop and manage comprehensive validation processes and procedures, including the upkeep and execution of the site Validation Master Plan and Data Integrity Governance Plan.
  • Oversee compliance with software and hardware validation regulatory requirements, such as 21 CFR parts 11, Annex 15 (Eudralex), GAMP, and other pertinent guidance documents.
  • Offer validation support and expertise for various projects, which includes creating Validation Plans, conducting validation impact assessments, system risk assessments, protocols, and reports.
  • Assist in regulatory submissions, failure investigations, CAPA initiatives, and ongoing improvement efforts.
  • Build and maintain collaborative relationships across the facility and with external customers to ensure quality and regulatory compliance in validation activities.
  • Prepare validation reports, data, and Key Performance Indicators for senior management presentations and Management Reviews.
  • Cultivate the leadership and operational skills of direct reports, establish career development plans, identify training needs, and set individual goals and objectives.
  • Conduct regular performance evaluations and provide constructive feedback.

 

Requirements:

  • Bachelor's Degree in a quality or science-related field (e.g., chemistry, biology, or medical technology) or equivalent professional training.
  • At least five (5) years of experience in drug manufacturing, medical devices, biologics, or a related industry.
  • Demonstrated experience in supervising and motivating teams, managing objectives, and conducting performance reviews.
  • In-depth knowledge of GMP, FDA regulations, SOP development, and a strong grasp of Validation and Data Integrity Principles.
  • Excellent analytical and problem-solving abilities, with a knack for presenting findings in clear, impactful reports.
  • Proficient in IT tools, including Microsoft Word, Excel, and PowerPoint.
  • Strong communication skills (both written and verbal), with the ability to effectively collaborate and present at all organizational levels.

 

Benefits:

  • We are committed to creating access and opportunities for all to develop and grow at your own pace.
  • Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.

 

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