Sr. Manager Quality

About the role

For our client, we are seeking a Sr. Manager Quality to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead the development and strengthening of quality systems that support a fast-moving biotech environment. The Sr. Manager Quality will partner closely with Regulatory and cross-functional stakeholders to ensure inspection readiness, compliance discipline, and operational rigor. This is a hands-on leadership role focused on building scalable quality practices while maintaining the speed needed to support the business. Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Support the buildout and implementation of a robust Quality Management System
• Define and maintain quality standards, SOPs, and process documentation across multiple quality environments
• Lead and manage internal and external audits, ensuring vendor qualifications
• Collaborate with Regulatory to align quality systems with submission and inspection requirements
• Oversee CAPA management, deviation handling, and change control processes
• Champion compliance with relevant ISO standards and quality certifications
• Foster cross-department relationships with a solutions-oriented approach

Qualifications

• 8+ years of quality experience in biotech or pharma, with exposure to GCP, GMP, or GLP
• Bachelor's degree in life sciences, chemistry, or a related field; advanced degree preferred
• Direct experience managing or supporting FDA and/or EMA inspections
• Proven ownership of Quality Management Systems, with skills in building or rebuilding them
• Ability to balance rigor with speed in a dynamic environment
• Prior experience at the Manager or Director level, with strong individual contributor capabilities

Benefits

• Medical, dental, and vision insurance
• Unlimited vacation and parental leave
• Employee assistance program
• Voluntary life and disability insurance
• Annual bonus potential
• 401(k) with a generous company match

Pay

$125,000 – $150,000 annually