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 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.
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
- 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
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.
