Senior QA Specialist, Quality Systems, GxP Training

The Opportunity:

• Support the continuous enhancement of the GxP Training Program within the Quality Systems function, ensuring training processes, curricula, and learning strategies meet business objectives and global regulatory requirements.

• Serve as the Quality Systems subject matter expert for GxP training, partnering cross-functionally with stakeholders to assess training needs, evaluate program effectiveness, and drive continuous improvement initiatives that strengthen compliance and operational excellence.

• Design, develop, and maintain the instructor-led and web-based GxP training curricula using GxP learning principles and instructional design methodologies to support onboarding, role-based qualification, and continuing education programs.

• Collaborate with functional leaders and SMEs to create engaging classroom training materials, eLearning content, facilitator guides, assessments, and blended learning solutions aligned with GxP requirements and job-specific competencies.

• Execution and administration of companywide GxP training programs, ensuring training assignments, curricula, and qualification requirements are aligned with job descriptions, procedural changes, and regulatory expectations.

• Evaluate the effectiveness of training programs through metrics, learner feedback, compliance trends, and quality data analysis; recommend and implement improvements to enhance learning outcomes and inspection readiness.

• Develop and implement scalable Quality Systems processes, strategies, SOPs, and Work Instructions related to GxP training management and electronic Quality Management Systems (eQMS).

• Drive a culture of quality, compliance, and continuous learning by influencing stakeholders, facilitating knowledge sharing, and promoting best practices in training and instructional design across the organization.

• Support cross-functional initiatives related to training process optimization, learning technologies, and quality system improvements without direct people management responsibilities.

Required Skills, Experience and Education:

• BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.

• Minimum 5+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.

• Experience in developing and implementing GxP quality systems to meet current regulatory and industry standards.

• Direct experience managing GxP document management and training systems.

• Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory requirements and ICH guidelines.

• Direct experience working with Veeva QualitySuite electronic platforms (QualityDocs, Training, QMS).

• Proficient with Microsoft Office including Word, Excel, PowerPoint experience is a plus.

• Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members.

• Ability to work independently and collaboratively across cross-functional teams in a dynamic environment.

Preferred Skills:

• Strategic thinking and project management skills.

• Direct experience with handling and/or participating in regulatory body inspections.

• A continuous improvement mindset and willingness to take initiative in solving problems.

• Experience in both virtual sponsor and scaling global organization models.

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