OverviewThe 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.
Essential Duties and 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.
Education and Experience- 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).
- 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).
Skills and Ability- Proven ability in quality/regulatory leadership.
- Strong planning, problem-solving, and risk management skills.
- Excellent attention to detail and ability to adapt to changing environments.
- Effective communicator with strong public speaking, interpersonal, and listening skills.
- Demonstrated business acumen and ability to make quick, well-thought-out decisions.
- Excellent organization and time management skills.
- Proficient in Microsoft Word, Excel, and database software.
- Fluent in English; additional language skills a plus.
Supervisory Responsibilities: Director
Physical Demands: While performing the duties of this job, the occupant is regularly required to:
- Prolonged periods of sitting at a desk and working on a computer.
- Prolonged use of computer and headphones for conference calls.
- Communicate effectively via phone, video, and email.
- Use hands and fingers to operate a computer and other office equipment.
Travel Requirements: Minimal
Join our team and discover how your work can
impact patients' lives around the world!
Some of the Perks our LabConnectors Love:- Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
- Health Benefits beginning on date of hire
- PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
- Short and Long-Term Disability, Life Insurance, and AD&D
- We celebrate our differences, which enriches our culture!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of
People First, Quality Focused, Customer Centered, Technology Driven, and
Accountability Always.
