QA Specialist V (Quality Risk Management)

TL;DR

QA Specialist V (Quality Risk Management): Leading cross-functional quality risk assessments and maintaining a site-wide QRM framework in a GMP-regulated life sciences manufacturing environment with an accent on risk-based decision-making, regulatory compliance, and continuous improvement. Focus on facilitating complex stakeholder discussions, strengthening risk governance, developing QRM training, and supporting audit and inspection readiness.

Location: Onsite in Portsmouth, New Hampshire, USA

Company

hirify.global is a global life sciences manufacturing company with more than 30 sites across five continents, producing medicines and supporting customers in developing viable therapies.

What you will do

• Lead cross-functional quality risk assessments and facilitate risk-based decision-making.
• Provide QRM expertise for site projects and operational initiatives.
• Maintain and improve risk registers, governance processes, and site procedures.
• Develop and deliver QRM training programs and drive their continuous improvement.
• Support audits, inspections, and regulatory readiness activities.
• Partner with Manufacturing, Quality Control, Engineering, and Technical Operations teams to identify and mitigate risks.

Requirements

• Bachelor’s degree in Life Sciences or a related field.
• Experience working in a GMP-regulated environment.
• Knowledge of Quality Risk Management principles and risk assessment methodologies.
• Strong analytical, problem-solving, decision-making, communication, and facilitation skills.
• Ability to manage multiple priorities and deliver results independently.
• Strong collaboration and stakeholder management capabilities.

Culture & Benefits

• Agile career environment with opportunities for professional growth and ongoing development.
• Exposure to cross-functional teams and senior stakeholders.
• Inclusive and ethical workplace grounded in collaboration, accountability, excellence, passion, and integrity.
• Performance-based compensation programs.
• Medical, dental, and vision insurance.