Job Summary
This role serves as a critical link between global policy and standard setting and the local implementation of these within the site business unit(s). It plays a fundamental part in safeguarding the quality and reliability of the organisation's data, essential for informed decision making and regulatory compliance.
Key Responsibilities:
* BUILD, LEAD AND MANAGE THE SITE DATA OPERATIONS & ENGAGEMENT, CULTURE & MONITORING (ECM) TEAM SUCCESSFULLY.
* DELIVER/IMPLEMENT SITE DATA GOVERNANCE (DG) RESPONSIBILITIES AND STANDARDS SUCCESSFULLY.
* ENGAGE AND MANAGE STAKEHOLDERS ACROSS THE SITE EFFECTIVELY.
* ESTABLISH A SUCCESSFUL RELATIONSHIP WITH THE GLOBAL GOVERNANCE TEAM (POLICIES & PROGRAMS) FOR CLEAR FEEDBACK.
* CREATE AND DELIVER DG TRAINING PROGRAMS IN CONSULTATION WITH GLOBAL DATA GOVERNANCE SENIOR LEADERSHIP TEAM.
* ENSURE THE TEAM IS PROPERLY RESOURCED, SUPPORTED AND HAS THE TOOLS AND DIRECTION TO EXECUTE THEIR FUNCTION.
* LEAD CULTURAL AND PEOPLE CHANGE MANAGEMENT EFFORTS RELATED TO DG FOR SMOOTH ADOPTION OF NEW PROCESSES, SYSTEMS AND WAYS OF WORKING.
* DEVELOP AND EMBED DG CULTURE ACROSS ALL ELEMENTS OF IOPS SITE WORK.
* DELIVER GLOBAL STANDARDS, POLICIES AND PROCEDURES AT SITE LEVEL AND MONITOR ADHERENCE.
* FOSTER A CULTURE OF QUALITY AND DG WITHIN THE ORGANISATION.
Requirements:
* TECHNICAL KNOWLEDGE IN BIOTECH OR PHARMACEUTICAL SECTOR WITH STRONG ANALYTICAL THINKING SKILLS.
* EXPERIENCE IN IMPLEMENTING DG POLICIES AND INITIATIVES WITHIN BUSINESS UNITS IN REGULATED ENVIRONMENT.
* CULTURAL/PEOPLE CHANGE MANAGEMENT EXPERIENCE AND DRIVING CULTURAL CHANGE RELATED TO DG.
* KNOWLEDGE OF APPLICABLE FEDERAL, STATE AND LOCAL REGULATIONS, RULES, POLICIES AND PROCEDURES.
* STRONG UNDERSTANDING OF DATA GOVERNANCE PRINCIPLES, REGULATORY REQUIREMENTS AND INDUSTRY STANDARDS.
* EXTENSIVE EXPERIENCE PARTNERING, INFLUENCING AND INCORPORATING NEW STANDARDS.
* STRONG PEOPLE MANAGEMENT AND TEAM LEADERSHIP EXPERIENCE.
* MANAGING AND IMPLEMENTING TRAINING PROGRAMS AND MONITORING KPI ACHIEVEMENT.
* STAKEHOLDER MANAGEMENT AND INFLUENCING SKILLS.
Qualifications:
A BA/BS degree and 12+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.