Sr. Director, Quality Assurance

Emmes•Rockville, WA

6d•Remote

About The Position

The 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.

Requirements

Bachelor's Degree Life Sciences, Pharmacy, Nursing, or a related field.
12+ years of experience within the pharmaceutical, biotechnology, or CRO industry.
7+ years experience in a Clinical Quality Assurance related role
5+ years direct people management experience, including leading global teams
Excellent verbal and written communication skills.
Strong understanding of quality risk management in the clinical research arena.
Excellent interpersonal and communication skills, with the ability to build relationships with stakeholders at all levels.
Demonstrated ability to lead and develop a high performing team.
Proficiency in using eQMS tools and other related software.
Strong analytical skills with the ability to interpret data and make data driven decisions

Nice To Haves

Master's Degree Life Sciences, Pharmacy, Nursing, or a related field.
Certified Quality Auditor, Certified Clinical Research Professional, Registered Quality Assurance Professional, or equivalent certification preferred.

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