You lead quality assurance and compliance efforts, ensuring adherence to regulations and corporate policies while guiding departmental strategy and participating in senior leadership discussions.
Anforderungen
- •Bachelor’s Degree in a science field
- •Master’s Degree preferred
- •10 or more years of industry experience
- •At least 8 years of management experience
- •Expert knowledge of ICH and FDA guidelines
- •Experience in regulatory inspections
- •Experience in quality system programs
- •Excellent written and oral communication skills
- •Strong leadership and management skills
- •Ability to work in cross-functional teams
- •Problem-solving ability for complex quality issues
- •Expert in 21CFR-Part11, GCP, and QSIT
Deine Aufgaben
- •Ensure compliance with relevant guidelines and regulations.
- •Oversee quality management and training initiatives.
- •Maintain corporate policies and procedures for compliance.
- •Ensure staff qualifications for regulated tasks and SOP adherence.
- •Provide strategic direction and leadership to the department.
- •Participate as a member of the Senior Leadership Team.
Deine Vorteile
Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans
Original Beschreibung
# Senior Director, Quality Assurance and Compliance
**Basel** | **Full time**
**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.
**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.