Associate Director CMC Regulatory Affairs - Quality Compliance - Quality Compliance

About the Role

We are seeking an Associate Director, Quality Compliance, CMC Regulatory Affairs to join our CMC Regulatory Affairs team, supporting our manufacturing and supply business area in an onsite work model at our Rensselaer location. This role offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Support management of the Quality Compliance group.
• Provide leadership across the broader CMC Regulatory Affairs organization.
• Champion consistent regulatory impact assessments and regulatory positions.
• Assess changes and deviations within the IOPS Quality Management System.
• Drive and support Corrective and Preventive Action plan ownership and closure.
• Represent Quality Compliance at regulatory, infrastructure, and cross-functional meetings.
• Lead process improvements, performance monitoring, and inspection readiness initiatives.
• Build alignment across teams and translate complex issues into clear decisions.

Requirements

• Bachelor’s degree in chemistry, biology, or a related discipline.
• 10+ years of experience in the biotechnology or pharmaceutical industry.
• Minimum 5 years of experience in CMC Regulatory Affairs or Quality.
• Experience with Quality Management Systems and regulatory impact assessments.
• Experience managing direct reports and leading teams.
• Ability to analyze complex information and communicate clear recommendations.
• Experience presenting complex regulatory or quality compliance matters to stakeholders.
• Ability to collaborate across cross-functional teams and build positive relationships.
• Ability to work effectively in ambiguous environments with minimal direction.
• Openness to change and a continuous process improvement mindset.

Qualifications

• CMC regulatory experience combined with Quality Management System experience is an advantage.

Pay

Salary Range (annually) $147,800.00 - $241,200.00