Overview
Sr. Director, Quality AssuranceThe Senior Director, Quality Assurance is a key member of the Quality Leadership Team providing quality assurance oversight for global clinical trials while supporting the broader Quality Management System (QMS) across the organization. This role directs the strategy, planning, and execution of the Clinical QA program and leads a global team of QA professionals. This role supports the VP, Quality & Compliance with inspection readiness, enterprise-level quality governance, metrics and trending, and QMS continuous improvement.
Responsibilities
- Provide ongoing leadership and oversight to sustain, optimize, and continuously enhance the global risk based Clinical Quality Assurance strategy to ensure compliance with international regulatory requirements (e.g., FDA, EMA, ICH GCP) and corporate standards.
- Lead the design and execution of the internal audit program ensuring QMS compliance and remediation of impacted groups
- Provide strategic leadership and oversight of the customer audit program, ensuring sustained audit readiness, effective hosting of qualification audits, and timely and accurate responses to questionnaires
- Lead and manage a global team of QA professionals, providing guidance, mentorship, and performance management.
- Champion the organization's inspection readiness program.
- Support the VP, Quality & Compliance in the preparation for, hosting of, and response to regulatory agency inspections.
- Review and approve audit reports, quality metrics, and CAPAs (Corrective and Preventive Actions) to ensure timely and effective resolution of quality incidents.
- Oversee QA responsibilities within the service providers management program.
- Foster a culture of quality, integrity, and continuous improvement within the organization.
- Performs other duties as assigned
- Complies with all policies and standards
Qualifications
- Bachelor's Degree Life Sciences, Pharmacy, Nursing, or a related field. Required
- Master's Degree Life Sciences, Pharmacy, Nursing, or a related field. Preferred
- 12+ years of experience within the pharmaceutical, biotechnology, or CRO industry. Required
- 7+ years experience in a Clinical Quality Assurance related role Required
- 5+ years direct people management experience, including leading global teams
- Certified Quality Auditor, Certified Clinical Research Professional, Registered Quality Assurance Professional, or equivalent certification preferred.
- Excellent verbal and written communication skills. High
- Strong understanding of quality risk management in the clinical research arena. High
- Excellent interpersonal and communication skills, with the ability to build relationships with stakeholders at all levels. High
- Demonstrated ability to lead and develop a high performing team. High
- Proficiency in using eQMS tools and other related software. High
- Strong analytical skills with the ability to interpret data and make data driven decisions High
If you're looking for a career where your work
advances global health and where
scientific excellence meets real-world impact, join us and be part of something bigger.
One Team, One Purpose.At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our
Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Work From Home Anywhere in the US
- Casual Dress Code & Work Environment
CONNECT WITH US!Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
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