Bridge Between Policy and Local Implementation
You will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s). This role plays a fundamental part in safeguarding the quality and reliability of the organisation's data, which is essential for informed decision making and regulatory compliance.
Key Responsibilities
* SUCCESSFUL BUILDING, LEADING AND MANAGING OF THE SITE DATA OPERATIONS & ENGAGEMENT, CULTURE & MONITORING (ECM) TEAM
* DELIVERY/IMPLEMENTATION OF SITE DATA GOVERNANCE (DG) RESPONSIBILITIES AND STANDARDS
* STAKEHOLDER ENGAGEMENT AND MANAGEMENT ACROSS THE SITE
* ESTABLISHING A SUCCESSFUL RELATIONSHIP WITH THE GLOBAL GOVERNANCE TEAM (POLICIES & PROGRAMS)
* CREATING AND DELIVERING DG TRAINING PROGRAMS IN CONSULTATION WITH GLOBAL DATA GOVERNANCE SENIOR LEADERSHIP TEAM
* ENSURING THE TEAM IS APPROPRIATELY RESOURCED, SUPPORTED AND HAS THE TOOLS AND DIRECTION TO PROPERLY EXECUTE THEIR FUNCTION
* LEADING CULTURAL AND PEOPLE CHANGE MANAGEMENT EFFORTS RELATED TO DG ENSURING SMOOTH ADOPTION OF NEW PROCESSES, SYSTEMS AND WAYS OF WORKING WITHIN THE RELEVANT SITE
* DEVELOPING AND EMBEDDING DG CULTURE ACROSS ALL ELEMENTS OF IOPS SITE WORK
* DELIVERING GLOBAL STANDARDS, POLICIES AND PROCEDURES AT SITE LEVEL AND MONITORING ADHERENCE TO THESE STANDARDS
* FOSTERING A CULTURE OF QUALITY AND DG WITHIN THE ORGANISATION AND PROMOTING THE IMPORTANCE OF DG ACROSS ALL DEPARTMENTS
* DRIVING COMMUNICATION AND COLLABORATION BETWEEN STAKEHOLDERS TO ENSURE EFFECTIVE DG PRACTICES
* INITIATIVES TO EMBED DG PRINCIPLES INTO THE COMPANY'S CORE VALUES AND EVERYDAY PRACTICES
Requirements
* TECHNICAL KNOWLEDGE WITHIN THE BIOTECH OR PHARMACEUTICAL SECTOR COUPLED WITH STRONG RELATIONSHIP BUILDING AND ANALYTICAL THINKING SKILLS
* EXPERIENCE IN IMPLEMENTING DG POLICIES AND INITIATIVES WITHIN BUSINESS UNITS IN A REGULATED ENVIRONMENT
* CULTURAL/PEOPLE CHANGE MANAGEMENT AND DRIVING CULTURAL CHANGE RELATED TO DG
* KNOWLEDGE OF APPLICABLE FEDERAL, STATE, AND LOCAL REGULATIONS RULES, POLICIES, AND PROCEDURES
* DATA GOVERNANCE PRINCIPLES, REGULATORY REQUIREMENTS AND INDUSTRY STANDARDS
* PRACTICAL APPLICATION OF THESE IN BUSINESS OPERATIONS
* EXTENSIVE EXPERIENCE DEMONSTRATING ABILITY TO PARTNER, INFLUENCE AND INCORPORATE NEW STANDARDS
* STRONG PEOPLE MANAGEMENT AND TEAM LEADERSHIP EXPERIENCE
* MANAGING AND IMPLEMENTING TRAINING PROGRAMS AND MONITORING KPI ACHIEVEMENT
* STAKEHOLDER MANAGEMENT AND INFLUENCING SKILLS
* ABILITY TO ADAPT IN THE FACE OF CHANGING BUSINESS NEEDS
Qualifications
* Bachelor's degree or higher in a relevant field
* 12+ years of professional experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT