Associate Director, Quality Systems Csv
**Job Title**: Associate Director, Quality Systems CSV
**Role Purpose**:
As an Associate Director, Quality Systems CVS, you will be responsible for identifying, managing, and reporting on the R&D teams compliance to quality, regulatory, legislative, and contractual requirements. Your role will involve defining and designing the R&D Quality Program, conducting audits and assessments, representing R&D in customer audits, and ensuring adherence to security, compliance, and audit requirements.
**Key Accountabilities**:
Strategy and Planning
- Define and structure the R&D Quality Program to meet regulatory and contractual requirements.
- Improve existing compliance programs and processes.
- Develop and modify organizational policies, standard operating procedures (SOPs), and work instructions.
- Design and execute audit procedures to measure R&D compliance.
- Compliance and Audit Assessments
- Manage compliance testing and monitoring of regulatory obligations.
- Conduct internal risk assessments and compliance audits.
- Establish relevant audit procedures based on industry standards.
- Collaborate with Legal, Regulatory, and Compliance teams to implement ISO27001.
Communication
- Develop effective materials and tools to communicate compliance requirements.
- Collect and analyze data for reports to senior management and regulators.
- Work closely with the Quality Team to ensure alignment and cadence.
- Collaborate with global Compliance colleagues and internal support functions.
**Knowledge, Skills & Attributes**:
- BA in life sciences or related discipline.
- Minimum of 5 years of experience in a regulated environment, preferably in healthcare GxP.
- Strong knowledge of legal and regulatory compliance standards.
- Experience with IT governance, risk, and compliance management.
- Strategic thinker with the ability to develop and implement business plans.
- Excellent presentation and project management skills.
- Strong communication and collaboration skills.
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Zajímavé nabídky práce v okolí:
Práce Associate Director, Quality Systems Csv: Často kladené otázky
👉 V jakém městě se nabízí nabídka práce Associate Director, Quality Systems Csv?
Práce je nabízena v lokalitě Praha.
👉 Jaká firma nabírá na tuto pozici?
Tato nabídka práce je do firmy Signant Health.