About

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Role Description

The Senior Director, Quality Assurance (QA) and Compliance is responsible for ensuring compliance with all relevant guidelines and regulations, overseeing quality management and training, ensuring that Veristat as a company has appropriate corporate policies, procedures, and infrastructure, and that staff are qualified to perform regulated tasks, and adhere to Standard Operating Procedures (SOPs).

The Senior Director, QA & Compliance is ultimately responsible for providing strategic direction and leadership to the department to best achieve departmental and company goals. In conjunction, s/he also participates as a member of the Senior Leadership Team.

Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

• 105+ approved therapies for marketing applications prepared by Veristat
• 480+ oncology projects in the past 5 years
• 350+ rare disease projects delivered in the past 5 years
• Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

Qualifications

• Bachelor’s Degree in a science or related field required; Master’s Degree preferred
• 10 or more years of relevant industry experience in Quality Assurance/Compliance required, with at least 8 years of direct management experience
• Expert knowledge of International Conference on Harmonisation (ICH), Food and Drug Administration (FDA), and other regulatory body guidelines
• Experience managing audits and/or FDA/European Union (EU) inspections
• Experience in participating in regulatory body inspections and inspection readiness activities
• Working experience in quality system programs of training, CAPA and document control
• Excellent written and oral communication skills
• Strong leadership and management skills
• Demonstrated ability to work in a cross-functional team environment
• Demonstrated problem-solving ability and aptitude to process complex quality issues
• Expert in relevant regulations and guidelines including 21CFR-Part11, GCP, and QSIT

Requirements

• Expert knowledge of ICH, FDA, and other regulatory body guidelines
• Experience managing audits and/or FDA/EU inspections
• Experience in regulatory body inspections and inspection readiness activities
• Working experience in quality system programs of training, CAPA, and document control
• Excellent communication skills
• Strong leadership and management skills
• Ability to work in a cross-functional team environment
• Problem-solving ability for complex quality issues
• Expert in regulations including 21CFR-Part11, GCP, and QSIT

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans