Senior Quality Strategist

6 days ago


Étreux, Hauts-de-France, United States Hydrogen Group Full time

Senior Quality Strategist - Biotech

We are seeking a highly experienced Quality Leader with a strong focus on Good Tissue Practices (GTP) and the assessment and implementation of regulations. This leadership role requires cross-functional collaboration across the organization, excellent communication skills, and a strategic mindset.

This opportunity is offered on an initial 6 month contracting basis, with potential for contract extension or conversion to full-time employment. As a w2 contract worker, you are eligible to a comprehensive benefits package including health, dental, vision, and life insurance, as well as a 401(k) vehicle.

This is a hybrid opportunity, located onsite in Boston, MA, yet could potentially be offered on a remote basis for the right candidate.

Compensation: The estimated annual salary for this position is $220,000-$242,000 based on a 40-hour workweek and assuming the hourly rate range of $100-110/hr.

Key Responsibilities:

  • Lead cross-functional teams to assess and implement regulations impacting the organization.
  • Provide regulatory guidance and industry-standard expertise.
  • Evaluate quality systems across GxP areas, ensuring comprehensive impact assessments.
  • Develop and execute strategies, timelines, and risk assessments for regulatory compliance.
  • Report on program progress, identifying and escalating risks as needed.

Qualifications:

  • Bachelor's degree in a scientific discipline, operations research/management, or related field.
  • 5-10 years of relevant experience in quality or regulatory environments.
  • Expertise in global GTP requirements and a strong understanding of GxP areas.
  • Exceptional facilitation, communication, and leadership skills.
  • Proven ability to lead teams and influence without authority.

About Hydrogen Group

H hydrogen group is a dynamic organization committed to excellence in the biotech sector. Our team is dedicated to providing top-notch quality services that exceed client expectations.



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