Covance by Labcorp have an opportunity for an Associate Director, Quality Assurance to join our QA group in EMEA.
Please note this role is working in Clinical Research. Quality Assurance leadership experience within Clinical Research (GCP / GXP) is essential.
Covance by Labcorp can be office or homebased within EMEA - we have some flexibiilty regarding location.
The Associate Director will have line management responsibility of a team of QA Managers and Senior Managers across the region, in addition to holding strategic and regional oversight.
Responsibilities will include:
- Staffing and oversight of regionally based QA lead team, ensuring the quality of interactions with clients in support of Quality Agreements, issue escalation and notification, corrective and preventive actions to client-specific issues, and quality governance
- Talent management, colleague performance management, development and engagement of regionally based team
- Providing regulatory compliance and quality assurance advice, guidance and support to internal CDCS teams and functions and collaborating with other internal stakeholders (e.g; Legal) for proactive client interactions and quality management
- Collaborating with the QA Management team to advance standards and requirements for the Client Engagement processes, including operational oversight and continuous improvement for proactive quality management
- Serve as key point of QA leadership contact in developing quality assurance strategies with Clients and CDS operations; serve as RCQA representation to operational and/or quality governance as appropriate
- Represent QA in client capability and proposal defense meetings as necessary
- Escalate key issues to management in a timely manner
- Supports Hosting of (complex) external audits/inspections e.g. regulatory inspections for strategic clients where needed
- Perform other duties, as assigned by management
- Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science / industry experience)
- Postgraduate degree (MSC or equivalent) in science or management related discipline preferable
- Experience may be substituted for education.
- Strong clinical research experience in a regulatory / quality environment (experience in GXP roles)
- Experience & regulatory expertise of industry quality systems/standards
- Ability to resource and lead a multidisciplinary team to drive strategic functional process improvement initiatives
- Ability to communicate and negotiate with external parties effectively
- Ability to distill critical information