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Jobs or company...

Senior Life Sciences Validation/QA Lead

Salary undisclosed

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Dice

Availability Status

This job is expected to be in high demand and may close soon. We’ll remove this job ad once it's closed.

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TECHNOGEN, Inc. is a Proven Leader in providing full IT Services, Software Development and Solutions for 15 years.

TECHNOGEN is a Small & Woman Owned Minority Business with GSA Advantage Certification. We have offices in VA; MD & Offshore development centers in India. We have successfully executed 100+ projects for clients ranging from small business and non-profits to Fortune 50 companies and federal, state and local agencies.


Job Title: Senior Life Sciences Validation/QA Lead
100% Remote
Long term Project
Job Summary: We are seeking a highly experienced Senior Life Sciences Validation/QA Lead to join our team. The successful candidate will be responsible for leading validation and quality assurance activities to ensure compliance with regulatory standards and the highest quality of our products and processes.
Key Responsibilities:
  1. Develop and Execute Validation Protocols:
    • Create and implement validation protocols for equipment, processes, and systems.
    • Oversee equipment qualification, process validation, and computer system validation.
  2. Quality Assurance Leadership:
    • Lead the QA team in designing and implementing QA processes, standards, and methodologies.
    • Ensure all validation activities comply with regulatory requirements and industry standards, such as cGMP.
  3. Documentation and Compliance:
    • Oversee the creation and approval of validation documentation, including SOPs, change controls, CAPAs, and deviations.
    • Ensure all documentation meets regulatory and company standards.
  4. Risk Management:
    • Identify and manage risks associated with validation activities.
    • Ensure critical parameters are controlled and maintained.
  5. Team Leadership and Development:
    • Mentor and lead a team of QA professionals.
    • Coordinate team activities and ensure alignment with project goals.
  6. Stakeholder Collaboration:
    • Work closely with project stakeholders to define testing objectives and deliverables.
    • Ensure QA activities meet project requirements and timelines.
Qualifications:
  • Bachelor's or Master's degree in Life Sciences, Engineering, or a related field.
  • Minimum of 8-10 years of experience in validation and quality assurance within the life sciences industry.
  • Strong knowledge of regulatory requirements and industry standards (e.g., cGMP, FDA, EMA).
  • Excellent leadership, communication, and project management skills.
  • Ability to work collaboratively with cross-functional teams.
Preferred Skills:
  • Experience with risk management and mitigation strategies.
  • Proficiency in validation software and tools.
  • Certification in Quality Assurance or related fields.
Thanks & Regards,
Hari
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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