Quality Assurance Manager

Job Title:
QA Manager / Senior QA Manager

Location:
New York

Reports to:
VP, Quality

Direct Reports:
None

Work Arrangement:
Hybrid (minimum 3 days in office)

About the Role

We are seeking an experienced
QA Manager / Senior QA Manager
to join a dynamic and growing organization. This role is pivotal in ensuring compliance with quality and cGMP/cGTP standards, providing oversight of ongoing manufacturing campaigns, and supporting the introduction of new product lines.

Key Responsibilities

• Manage QA operations for contractors to maintain compliance with regulatory and internal quality standards.
• Oversee manufacturing campaigns and ensure adherence to cGMP/cGTP requirements.
• Support the introduction and qualification of new product lines.
• Collaborate cross-functionally to uphold quality systems and continuous improvement initiatives.

Experience & Qualifications

• Bachelor's degree in Life Sciences or a related discipline.
• Minimum 8 years of collective experience in quality management, including at least 4 years in pharmaceuticals or biotechnology.
• Strong knowledge of TGA, FDA, and EU GMP regulations, as well as other quality-related systems (e.g., ISO Standards, ICH, PIC/s).
• Proven ability to work in small to mid-sized organizations.

Ideal Candidate

You thrive in a collaborative environment, have a strong understanding of global quality standards, and can effectively manage QA operations without direct reports.