Associate Director, Clinical Quality & Compliance (Remote)

Talanto; Northern (KY); Hybrid; USD 148,000 - 204,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

Vacation 15 days + shutdown

Holidays + personal days

Sick time 80 hours

Parental Leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Job summary

Talanto is seeking an Associate Director, Quality Assurance & Governance to lead quality and compliance across RDQC in clinical development. You will oversee QMS enhancements, SRAs, CAPAs, investigations, and vendor governance while guiding cross-functional teams and ensuring regulatory alignment.

The role emphasizes inspection readiness, risk management, and continuous improvement, with remote work preferred for candidates in Eastern or Central Time Zones.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline.
• Minimum 10 years of experience in Clinical Operations, Clinical Quality, Compliance, or related pharma/biotech functions.
• Extensive knowledge of GCP regulations, FDA/ICH, and international requirements.
• Experience supporting quality oversight in clinical development programs.
• Experience leading investigations, CAPA, and effectiveness verification.
• Strong QMS, risk management, metrics, and continuous improvement knowledge.
• Experience with regulatory inspections, sponsor audits, and internal audits.
• Experience with vendor oversight and Vendor Quality Governance.
• Excellent analytical, problem-solving, and communication skills.
• Ability to influence without authority and collaborate across functions.
• Clinical trial systems and processes expertise.

Responsibilities

• Provide expert guidance on quality and compliance for assigned studies and programs.
• Develop and improve the Quality Management System and governance processes.
• Lead quality oversight activities including SRAs, health assessments, trends, and risk mitigation.
• Consult study teams on GCP requirements, standards, and regulatory expectations.
• Lead investigations related to deviations and quality events and approve CAPA plans.
• Oversee root cause analysis, CAPA implementation, and verification of effectiveness.
• Drive Vendor Quality Governance activities and vendor qualification/oversight.
• Support audits, sponsor audits, investigator site audits, and inspections.
• Identify emerging compliance risks and implement proactive mitigations.
• Lead cross-functional quality improvement initiatives and monitor trends.

Skills

Quality governance

GCP compliance

Risk management

CAPA oversight

Investigations

Vendor oversight

Audit readiness

Cross-functional leadership

Study risk assessments

Quality metrics

Regulatory inspections

Data integrity

Stakeholder management

Education

Bachelor's degree

Job description

Talanto is seeking an Associate Director, Quality Assurance & Governance to lead quality and compliance across RDQC in clinical development. You will oversee QMS enhancements, SRAs, CAPAs, investigations, and vendor governance while guiding cross-functional teams and ensuring regulatory alignment.

The role emphasizes inspection readiness, risk management, and continuous improvement, with remote work preferred for candidates in Eastern or Central Time Zones.