Job Description:
Senior Director, Quality Assurance and Compliance
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
What we offer
Benefits vary by location and may include:
Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans
What we look for
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 with 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, and demonstrated problem-solving ability and aptitude to process complex quality issues.
Expert in relevant regulations and guidelines including 21CFR-Part11, GCP, and QSIT.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
#LI-SI1
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.