Director Quality Management Compliance

Provides leadership and management of the QA team and business partners responsible for overseeing Quality Management System activities

Provides input into the internal global audit program identifying risks and determining the number and types of audits to be conducted each year.

Oversees and supports the scheduling conduct and reporting of audits and reviews of activities in area of expertise e.g. IT/Technology platforms computer system validation (technical) vendors data management activities.

Provides oversight of the escalated Issues Management program including the review approval tracking and closure of escalated Quality Issues (QIs) CAPAs and Deviations.

Mentors a team of quality professionals and makes sure that quality deliverables are provided ontime in compliance with Ergomed standards regulatory requirements and client expectations.

Develops and drives continuous process improvements leading managing and directing specific assigned projects

Lead training activities and contribute to policy making decisions as a resource in area of expertise

Acts as the key contact and leads the preparation and hosting of sponsor audits specific to area of expertise

Provides guidance and oversight for the analysis of Root Cause and CAPA plans for quality issues (QIs) and audit findings related to relevant area of expertise.

Provide input and guidance on the interpretation of regulatory requirements GxP and clinical research related activity guidelines e.g. GAMP5

Participate in system risk assessments and implementation activities for e.g. IT systems.

Writes and reviews Quality Assurance departmental controlled documents and reviews other CRO department controlled documents for GCP compliance

Qualifications :

Degree qualified in a Life Science related subject

        Demonstrated experience working in a CRO environment with a focus of GCP Quality

        RiskBased Quality Experience Proven success anticipating industry trends and regulatory requirements to manage business risk compliance and sustainability

        In depth knowledge of the drug development process and worldwide regulatory requirements

        Excellent communication management and collaboration skills

        Demonstrated ability to lead crossfunctional teams

        Ability to handle multiple tasks to meet deadlines in a dynamic environment

        Effective organizational presentation documentation and interpersonal skills

        Effective problem solving and decision making

        Strong customer focus

Additional Information :

We offer: 

• Training and career development opportunities internally  

• Strong emphasis on personal and professional growth 

• Friendly supportive working environment 

• Opportunity to work with colleagues based all over the world with English as the company language 

Our core values are key to how we operate and if you feel they resonate with you then Ergomed is a great company to join!  

Quality 

Integrity & Trust  

Drive & Passion  

Agility & Responsiveness  

Belonging 

Collaborative Partnerships  

We look forward to welcoming your application. 

Remote Work :

Yes

Employment Type :

Fulltime