O pozici
Seeking a full-time Business System Associate Director for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.
Co budeš dělat
- Manage and lead Business Analysts for complex data analytics application
- Lead System Development, Maintenance, Enhancement and System Monitoring related initiatives
- Serve as a liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business Requirements and ensuring the system is aligned to meet the business needs
- Facilitate System Operations Mtgs including discussions to resolve issues and manage competing priorities utilizing proper escalation pathways to ensure limited impact to delivery timelines for workstream activities
- Lead the development of User facing System Resources ensuring supporting materials remain aligned with the current system version.
- Work collaboratively with stakeholders in Global Labeling, System Support Team, IT and Learning & Development organizations to meet required delivery timelines associated with User Resources
- Lead System Releases in collaboration with IT Business Partners including activities relating to Requirements Gathering, Documentation, Testing, Implementation, Deployment and Hypercare phases
- Facilitate and oversee the System Support Model for systems within remit including: Monitor user support cases, ensuring thorough root cause investigations are conducted, CAPAs are detailed and closed effectively and communication is consistently done to reduce instances of recurrence.
- Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users
- Conduct System Administrator activities supporting the alignment of the Global organizational processes with the System Capability cross-functionally and cross-regionally
- Facilitate System Specific Global User Group Forums, Release/System Communication authoring and Program Updates, as requested
Koho hledáme
- BS/BA in science, engineering, IT or related discipline with functional working experience in System Development/Management within GxP regulated areas preferred
- Requires 10+ years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and Digital Enablement experience strongly preferred, and applied knowledge of SDLC and IT System/Business System Management
- Candidate must be proficient with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process
- Must have experience with audit/inspection facing support for GxP systems and ability to communicate complex concepts in high pressure situations
- Analytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives
- Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information
- Effortlessly works in a collaborative manner with cross-functional and cross-regional users and stakeholders while building strong working relationships
- Effective communication skills (verbal and written)
- Ability to work cooperatively with others and provide significant contributions as a member of a team in addition to serving in a leadership capacity
- Strong organizational skills
- Demonstrates strong attention to detail
- Process-oriented and proficient with GxP (GMP) requirements with experience working in a highly regulated industry
- Experience with business process mapping and system design for workflow management is an asset
- Strong aptitude for authoring Technical Guidance documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is required
- Good understanding of SDLC Documentation requirements and processes pertaining to system management for GxP/GMP applications
Benefity
- Exciting work in a great team, global projects, international environment
- Opportunity to learn and grow professionally within the company globally
- Hybrid working model, flexible role pattern
- Pension and health (Canadian Medical) contributions
- Internal reward system plus referral program
- 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
- Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport card, Vodafone, Raiffeisen Bank and Foodora discount programs
- Up-to-date laptop and iPhone, parking in the garage, showers, refreshments
- Competitive salary, incentive pay, and many more
