Director of Quality

Argenta•Shawnee, KS

84d•Onsite

About The Position

Argenta is seeking a Director of Quality (Clinical) for its Shawnee, KS location. This role will oversee all aspects of the clinical Quality department across the Americas CRO business. The company is a global team dedicated to healthier animals, supporting companies in developing and manufacturing health products for pets and livestock. Argenta is the world's only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health. They are described as ambitious, growing, and building a 'one team' culture guided by their values: team players, doers, customer-centric, and innovators. They value diversity and believe in the richness of working with different people in different places. With bases in New Zealand, the US, the UK, and Europe, their 900+ colleagues are driven by their partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together.

Requirements

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
4+ years of supervisory experience
Demonstrated 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
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

Nice To Haves

Animal Health experience highly preferred

Responsibilities

Manage, lead and oversee all aspects of Quality department 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
Ensure the team has the skillset to support the following: drafting of QA and Data Management Plans, full capability to ensure drugs received for studies comply with regulatory, protocol and SOP compliance, auditing of protocols and Final Study Reports.