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This leadership role is highly visible within the global Labcorp by Covance Clinical Development & Commercialization Services (CDCS) business and is central to delivering Covance’s value proposition to potential clients and is an active member of the global Regulatory Compliance and Quality Assurance leadership. This positon is required to partner with executive Covance leaders to support the growth strategy and to drive a culture of GCP quality, compliance, and continuous improvement in the organization.. As lead Quality and Compliance subject matter expert, this role manages complex issues and regulatory inspections
The incumbent in this role drives the continual success of the APAC QA team as well as oversees the Asia Pacific strategy and delivery of the audit (internal, contracted and vendor) and of the customer audit/inspection programs; and, the delivery of commitments made to clients in quality agreements.
- Providing strategic direction, delivery & oversight of the Asia Pacific audit & inspection function;
- Driving proactive compliance excellence through execution of key audit/inspection activities, identifying areas of opportunity, appropriate escalation and messaging as well as trending and communicating in governance forums
- Partnering with senior clinical research leadership to ensure effective inspection preparedness programs are implemented and to assure customer satisfaction
- Partnering with global Regulatory and Quality Assurance leaders across business units to drive consistent QMS implementation and roll out of related global initiatives
- Providing regulatory compliance and quality assurance advice, guidance and support to internal clinical development study teams and functions and assuring quality agreements made to clients are fulfilled.
- Collaborating with internal stakeholders for proactive interactions and quality management
- Representing Covance in industry quality forums.
Why join Covance by Labcorp?
For starters, we’re the most comprehensive CRO in the industry (Drug development through to post marketing surveillance). What else makes us different?
- Exceptional experienced employees working together in a culture that emphasizes continuous learning and rewards success
- Supportive global leadership that provide you a platform to develop and grow your experience.
- Be part of a global team that works on wide range of therapeutic areas from Phase I – Phase IV
- Join a friendly welcoming culture with opportunities to work from home
- Be valued – partner with key regional leadership stakeholders to recommend and develop localized strategies to meet business and client expectations
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
Travel: = 30%
- Typically, 10+ years in a clinical trial regulatory environment with extensive experience in Good Clinical Practice (GCP roles)
- Proven experience interpreting new/updated regulations, facilitating assessment on impact on business / QMS for adoption
- Ability to effectively cast/communicate quality strategy to internal parties
- Ability to network within the global QA organization to drive consistent global QMS implementation/maintain global connectivity
- Ability to distill / communicate critical information
- Experience and ability to effectively lead QA teams/staff in multiple geographic locations
- Wide experience working in various cultural settings /ability to tailor communication approaches for effective/impactful collaboration
- GCP consultation skillsets for multidisciplinary leaders and teams to drive strategic business process improvement initiatives
Experience leading / engagement in regional pharmaceutical industry GCP forums
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