Director of Quality

Argenta; Shawnee (KS); On-site; USD 140,000 - 190,000; Full time

Job summary

Argenta is seeking a Director of Quality (Clinical) at our Shawnee, KS location to lead the Americas CRO quality program and embed quality in operations across clinical, pre-clinical and CDO activities. The role focuses on risk-based, science-based quality strategies and sustained inspection readiness.

The ideal candidate brings 10+ years in quality within regulated environments, 4+ years in management, and preferably Animal Health experience; strong auditing, leadership, and collaboration

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 10+ years in a quality role in a highly regulated environment, with 4+ years in a supervisory role.
• Animal Health experience preferred.
• RQAP-GLP or GCP preferred.
• Autonomy to lead a large, multi-functional quality department and partner with executives.
• Progressive leadership in GCP/GLP environments.
• Collaborative leadership style across all levels and functions.
• Understanding of the GCP space and external audits.
• Experience auditing study protocols per GCP guidance and study data/audits.
• Experience with internal inspections/audits and EDC systems; strong MS Office skills.
• Willingness to travel; valid driver’s license and travel documentation.

Responsibilities

• Manage and oversee clinical, pre-clinical and CDO Quality across Americas CRO.
• Develop and implement quality strategies for regulatory compliance and continuous improvement.
• Oversee QA/QC across business units for consistency and compliance.
• Build and lead a high-performing team with coaching and cross-functional partnership.
• Manage quality systems/files across Americas CRO.
• Coordinate and perform internal audits and activities as requested.
• Perform vendor, laboratory, and clinical site inspections/audits.
• Audit SOP programs and training files; close corrective actions.
• Provide oversight during regulatory and client inspections.

Skills

Quality leadership

GCP/GLP knowledge

Auditing / lead auditor

Regulatory compliance

Communication

Team leadership

Data analysis

EDC systems familiarity

Travel readiness

Microsoft Office proficiency

Education

Bachelor's degree in a scientific discipline

Tools

EDC systems

Job description

At Argenta, we’re more than a company — we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.

Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market.

We’re in a unique position. We are the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health.

We are ambitious, growing and building a ‘one team’ culture, guided by our values.

• We are team players;
• We are doers;
• We are customer-centric;
• We are innovators.

We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best “paw” forward we will make the lives of the animals we care for, better.

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.

TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply.

Argenta is currently looking to fill the role of Director of Quality (Clinical) at our Shawnee, KS location. This position will overall all aspects of the clinical Quality department across the Americas CRO business.

Key Responsibilities

• Manage, lead and oversee all aspects of clinical, pre-clinical and CDO Quality departments across Americas CRO embedding quality within operations and facilities using a risk-based, science-based approach
• Develop and implement quality strategies that ensure scientific integrity, regulatory compliance, operational excellence and continuous improvement leading to controlled documentation and sustained inspection/audit readiness
• Oversee QA and QC functions across business units within Americas CRO ensuring consistency and compliance
• Build and lead a high performing team, embedding a culture of quality through coaching, training and cross-functional partnership
• Manage and maintain quality systems and files across Americas CRO
• Coordinate and perform internal audits and activities as requested
• Perform qualification inspections/audits of selected vendors, laboratories, and clinical study sites
• Conduct inspections/audits of company SOP programs and files (Qualification and Training files, SOP systems, Archiving, etc.)
• Perform follow-up reviews of audit findings to confirm corrective actions have been completed
• Provide oversight and participation in inspections by regulatory agencies and clients

About You

• Bachelor’s degree, preferably in a scientific discipline or equivalent experience
• Minimum of 10 years’ experience in a quality role in a highly regulated industry, including 4+ years of supervisory experience
• Animal Health experience highly preferred
• RQAP-GLP or GCP preferredDemonstrated autonomy to lead a large, multi-functional quality department, drive enterprise-wide quality strategy, and partner with executive and operational stakeholders in a regulated environment
• Progressive quality leadership experience in GCP and GLP compliant organizations
• A collaborative working style to be able to lead and motivate people at all levels and across all functions in an organization
• Understanding of the GCP space
• Experience conducting/acting as lead auditor for external audits
• Experience conducting audits of study protocols in accordance with GCP guidance
• Experience conducting study data audits
• Experience auditing study reports (Final Study Reports (FSRs)
• Experience conducting internal inspections/audits.
• Experience working with EDC systems (Electronic Data Capture)
• Position requires significant computer skills including the ability to use Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
• The employee must possess a valid driver’s license and proper travel documentation i.e., passport, and have the ability to travel
• Excellent oral and written communication skills
• Strong analytical thinking and problem-solving skills
• Capable of working in a changing environment and under pressure
• Supports organizational goals and objectives aligned to strategic and/or operations plans

Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.

Argenta is an equal-opportunity employer