What You’ll Do

• Develop the framework for Global Regulatory CMC business processes; determine the appropriate hierarchy; and ensure maintenance of the processes and compliance to them
• Serve as liaison to Business Process Management (BPM) team within Operations Systems Improvements (OSI)
• Identify business process owners (BPOs) for all business processes owned by Global Regulatory CMC; establish and drive community of practice comprised of BPOs 
• Identify business processes of which Global Regulatory CMC is a part (but does not own); ensure appropriate SME representation for those processes
• Work closely with Global RegCMC CI Lead to identify areas for improvements within Global RegCMC processes
• Oversee E2E processes and their improvements that support Global RegCMC Operating Model
• Responsible for managing and overseeing the objectives and performance of a process through Key Performance Indicators (KPI)
• Drive the creation and maintenance of the Global RegCMC Quality Manual in line with Global RegCMC strategy
• Contribute to planning, process and continuous improvement within Global RegCMC
• Together with CI Lead, lead improvement initiatives identified by Global RegCMC LT in order to improve processes and effectiveness
• Coordinate creation and maintenance of supporting Policies, Standard Operating Procedures and standards
• Ensure maintenance of Job Descriptions, CVs and training plans across Global RegCMC organization
• Governance of operational support model, including operational procedures and user administration

Required Skills

• 7+ years experience (ideally in the pharmaceutical/biotechnology industry) plus 4 years Global CMC regulatory experience and / or Regulatory Operations
• Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals
• Demonstrate excellent leadership and emotional intelligence, along with verbal and written remote working communication skills
• Demonstrated competency in planning and tracking projects of high complexity and risk with clearly defined critical paths; delivering projects on time and on budget
• Proven ability to create strong working relationships in a global setting with many different cultures
• Enthusiastic orientation to teamwork: works collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties
• Project Management skills

Preferred

Bachelors degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science

Who You Are

In this role, you will be part of Global RegCMC Strategic Operations and Business Excellence team and will report to Head of this team.  This candidate must have proven internal and external leadership and abilities to work cross-functionally globally.  Strong communication and interpersonal skills.  Ethically interacts with multiple international, cross-functional departments, and industry peers at all levels. Customer focused, interacts with a wide variety of outside contacts, including contractors, corporate partners, and regulatory agency personnel.