Director, Quality Operations

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Develop and implement the annual US Quality Plan in alignment with the global strategy.

• Oversee US Quality Assurance operations and Global Quality Control activities.

• Provide guidance to US Operations and senior leadership on quality strategy, regulatory obligations, and compliance risks.

• Lead strategic initiatives aimed at fostering a quality culture and enhancing processes and outcomes.

• Supervise design verification and quality control review procedures.

• Direct the review processes for study QC support documentation.

• Establish and track US QA and Global QC metrics; report results and suggest improvements.

• Engage in quality-event investigations and plan CAPA activities.

• Draft, review, and approve Project Quality Control Standard Operating Procedures (SOPs).

• Coordinate and facilitate client audits and prepare the organization for regulatory inspections.

• Collaborate with various departments to ensure QC reviews are in line with current processes and standards.

• Conduct regulatory and compliance risk assessments during contractual negotiations.

• Work in partnership with global QA and IT teams on systems validation and compliance projects.

• Supervise, mentor, and develop Quality Control Specialists and other team members.

• Oversee the creation of training materials and ensure staff readiness for evolving quality standards.

• Interact with laboratory, customer service, business development, project management, IT, and data management teams.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related discipline (required).

• Over 10 years of experience in a clinical or laboratory setting with progressively increasing responsibility in quality assurance/control (required), or a combination of roles in Life Sciences with a focus on Quality and Regulatory.

• At least 4 years of leadership experience, including direct supervision of teams (required).

• Experience in clinical trials and laboratory settings with an emphasis on GCP/GxP (preferred).

• Global work experience with teams and clients across diverse cultures and time zones (preferred).

• Research Quality Association Cert-GCP or Cert-GCLP, or EOQ Certified Quality Auditor (preferred).

• Demonstrated capability in quality/regulatory leadership.

• Strong skills in planning, problem-solving, and risk management.

• Exceptional attention to detail and adaptability to changing environments.

• Effective communication, public speaking, interpersonal, and listening skills.

• Proven business acumen and the ability to make timely, well-informed decisions.

• Excellent organizational and time management abilities.

• Proficient in Microsoft Word, Excel, and database software.

• Fluent in English; proficiency in additional languages is advantageous.

• Capability to perform prolonged desk work, including computer, headphone, phone, video, and email tasks.

• Availability for minimal travel.

🏝️ Benefits

• Minimal travel requirements.