Senior Director, Quality Control

Scorpion Therapeutics; Madison (WI); On-site; USD 190,000 - 230,000; Full time

Benefits offered by this job

On-site role

Job summary

Arrowhead Pharmaceuticals seeks a Lead for the Quality Control (QC) Laboratory to oversee analytical, microbial, stability, and reference standard testing across oligonucleotide and biologics platforms.

The role involves establishing and optimizing QC processes, ensuring GMP compliance, and leading the transition from clinical to commercial readiness, with on-site work in Verona, WI and some travel.

Qualifications

• 15+ years in GxP pharma/biotech industries.
• 7+ years leading QC operations in a cGMP setting.
• Experience with FDA inspections and regulatory readiness.
• Collaborates with Manufacturing, MSAT, Regulatory and Analytical Development teams.

Responsibilities

• Lead a multi-manager QC team and set strategic vision, budgeting and resource allocation.
• Ensure QC support for manufacturing, process validation and regulatory inspections.
• Represent QC during FDA Pre-Approval Inspections and commercial launches.

Skills

GxP leadership

Budget management

cGMP experience

Regulatory liaison

Cross-functional collaboration

Quality systems

Education

Master's degree in science

PhD preferred

Job description

Role:

Lead the Quality Control (QC) Laboratory at Arrowhead Pharmaceuticals, overseeing analytical, microbial, stability, and reference standard testing across oligonucleotide and biologics platforms.

Objectives

• establishing and optimizing QC processes, ensuring GMP compliance, and leading the transition from clinical to commercial readiness.

Responsibilities

• Responsibilities involve managing a multi-manager QC team, setting strategic vision, operational planning, budgeting, and resource allocation.
• The role also requires ensuring QC support for manufacturing, process validation, and regulatory inspections, notably serving as a QC representative during FDA Pre-Approval Inspections.

Qualifications:

• 15+ years in GxP pharma/biotech industries
• 7+ years of direct QC operations leadership in a cGMP setting, including managing budgets and multiple managers
• Master's degree in a scientific field, with PhD preferred
• High-value specifics include expertise in GMP, FDA, ICH regulations, and supporting FDA PAI and commercial launches
• Position entails close collaboration with Manufacturing, MSAT, Regulatory, and Analytical Development teams

Location

Work setup is on-site in Verona, WI, with some travel expected.