Director, Quality Operations
About The Position
The Director, Quality Operations for the US provides strategic leadership and oversight of quality operations across US sites, ensuring compliance with global standards and regulatory requirements. This role partners with senior leadership to drive quality strategy through continuous improvement initiatives, ensure compliance with global standards and regulatory requirements, and oversees US quality assurance and Global quality control activities. The Director supervises and develops the Global Quality Control team, ensuring operational excellence and readiness for audits, inspections, and client deliverables with measurable impact through quality metrics.
Requirements
- Bachelor’s degree in life sciences or related field (required).
- 10+ years of experience in a clinical or laboratory environment with increasing responsibility in quality assurance/control (required), Or a combination of roles in Life Sciences, focused on Quality and Regulatory.
- 4+ years of leadership experience, including direct supervision of teams (required).
- Proficient in Microsoft Word, Excel, and database software.
- Fluent in English
Nice To Haves
- Experience in clinical trials and laboratory environments with focus on GCP/GxP (preferred).
- Global work experience with teams and clients across cultures and time zones (preferred).
- Research Quality Association Cert-GCP or Cert-GCLP, or EOQ Certified Quality Auditor (preferred).
- additional language skills a plus.
Responsibilities
- Develop and execute the annual US Quality Plan aligned with global strategy.
- Provide oversight of US Quality Assurance operations and Global Quality Control.
- Advise US Operations and senior leadership on quality strategy, regulatory requirements, and compliance risks, providing insights that inform business decisions.
- Lead strategic projects that enhance quality culture and deliver measurable improvements to processes and outcomes.
- Oversee design verification and quality control review processes to ensure project designs meet client needs per protocol, OSD, and budget.
- Direct study QC support documentation reviews and ensure timely, thorough completion.
- Establish and monitor US QA and Global QC metrics; report outcomes to leadership and recommend improvements.
- Participate in investigations of quality events and associated CAPA planning, identifying and remediating process gaps leading to continuous improvement of Operations.
- Author, review, and approve Project Quality Control SOPs in alignment with industry best practices and evolving regulatory standards; contribute to broader departmental SOPs.
- Coordinate and host client audits; ensure organizational readiness for regulatory inspections through gap analyses and remediation when needed.
- Collaborate across departments to ensure QC reviews align with current processes and standards.
- Provide regulatory and compliance risk reviews of contractual negotiations.
- Partner with global QA and IT staff on configurable systems validation and compliance initiatives, ensuring harmonization across regions.
- Supervise, coach, and develop Quality Control Specialists and other team members.
- Oversee creation of training materials and ensure staff readiness for evolving quality standards.
- Interface with laboratory, customer service, business development, project management, IT, and data management teams.
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What This Job Offers
Job Type
Full-time
Career Level
Director
