Are you ready to step into the role as Global Business Process Owner (GBPO) for QC Laboratory Controls?

In this role you will set the strategic direction for our five FLB sites in US, UK and DK. This includes cascading process requirements across the global network and driving transparency, alignment and continuous improvement. In addition, you will have the ownership of the overall Policy for Laboratory Controls, including the document hierarchy and end-to-end process.

As a GBPO, you are the senior process Subject Matter Expert (SME) and leader with cross-site accountability and decision-making authority, overseeing up to 10 employees in a matrix organization.

Key Responsibilities

• Set the Strategic Direction: Define process strategy and provide guidance to sites.  Perform Regulatory Intelligence to ensure regulatory requirements are embedded in the process. Ensure Inspection Readiness of the process.
• Own the End-to-End Process: Create and maintain compliant global processes, build standardized processes, own global documents and ensure alignment with the QMS infrastructure. Develop process training structure for implementation at the sites.
• Cascade process requirements across the global network. Train and coach Local Process Owners. Develops a Global Community of Practice to provide framework for engagement and alignment across sites.
• Drive transparency, continuous Improvement and change. Encourage cross site collaboration.

Qualifications & Experience

• M.S. degree or PhD within biotechnology, pharmacy, engineering or similar.
• Preferable a minimum of 15 years of experience within pharmaceutical industry (with GMP knowledge; FDA, EMA, MHRA).
• Proven managerial experience with people and project management.
• Expertise in developing and executing strategic agendas.
• Ability to communicate effectively with senior and executive leadership.
• Experience in presenting during regulatory inspections and customer audits.
• Capability to unify multiple sites and functions towards common objectives.
• Navigate ambiguity with risk management expertise.
• Proficient in both written and verbal communication.

Scope & Decision Making

•  Makes and influences decisions across the business and externally (eg: regulatory agencies, outsourced partners, etc...).
•  Able to work independently and with minimal direction.
• The GBPO will have a high sense of responsibility.
• Able to navigate in complex projects to influence QCs decision making.

Key Skills

• Knowledgeable of regulations driving the core business (e.g. FDA, EMA, MHRA). 
• Expertise within their assigned process.
• Knowledgeable of systems supporting their process.
• Core understanding of integration and interactions with other processes.
• Basic knowledge of operations at each site.