Specialist/SR Specialist, PV Sys & Data Analysis

Boehringer Ingelheim GmbH; Johns Creek (GA); On-site; USD 110,000 - 160,000; Full time

Job summary

Boehringer Ingelheim is seeking a Specialist/SR Specialist for PV Systems & Data Analysis in Johns Creek, GA. The role focuses on executing Global PV processes for computerised systems administration and data analysis, ensuring compliance with PV SOPs and regulatory requirements.

You will act as a subject matter expert, guide system administration across environments, and lead the Change Advisory Board to resolve issues while maintaining compliance.

Qualifications

• Bachelor's degree from an accredited institution in biology, statistics, or IS/IT.
• Two years of GMP/compliance data analytics experience, or five years in GMP.
• Advanced degree (MSc, MBA) preferred.
• Experience with PVWorks, Trackwise or similar validated databases.
• Experience with databases and database system support.
• Regulatory/compliance experience required.
• Proficiency with SQL and SQL software tools, QlikView and/or Crystal Reports.
• Knowledge of Animal Health Regulatory/Pharmacovigilance laws and guidelines.
• Ability to maintain composure under pressure and meet strict timelines.
• Strong problem solving, prioritization and end-to-end thinking.
• Ensure compliance with diverse regulatory authorities worldwide.

Responsibilities

• Subject Matter Expert for PV Systems
• Implements PV Systems Change Controls
• Guides and trains users for system use and data retrieval
• Leads the Change Advisory Board
• Investigates and resolves Level 2 system issues
• Ensures system compliance with corporate procedures and regulatory requirements

Skills

PV systems expertise

Regulatory compliance

SQL proficiency

Analytical thinking

Communication skills

Team collaboration

Problem solving

Education

Bachelor's degree in Biology/Statistics/IS/IT

Advanced degree (MSc, MBA) preferred

Tools

PVWorks

Trackwise

SQL software tools

QlikView

Crystal Reports

Excel (advanced graphing)

Job description

Specialist/SR Specialist, PV Sys & Data Analysis

Description

Execute activities associated with the Global PV processes for PV Computerized Systems Administration and Data Analysis. Monitor these processes to ensure continued compliance with all BIV PV SOPs and competent health authority regulations. Identify areas which require change to maintain compliance and develop solutions. Subject Matter Expert for PV Systems, database administration, computerized system validation and data retrieval. Manages projects under direction of Principal Specialist and/or PV Systems and Data Analysis Manager. Acts as a resource to support PV (global and local). As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

Specialist:

• Subject Matter Expert for PV Systems
• Implements PV Systems Change Controls
• Provides guidance and support for PV Systems Administration for all environments (dev, val, prod, train)
• Guides and trains Users with system use and data retrieval needs
• Leads the Change Advisory Board
• Responsible for investigating and resolving Level 2 system issues
• Ensures system remains compliance with corporate procedures and multiple regulatory authorities’ requirements
• Subject Matter Expert for PV Systems
• Implements PV Systems Change Controls
• Provides guidance and support for PV Systems Administration for all environments (dev, val, prod, train)
• Guides and trains Users with system use and data retrieval needs
• Leads the Change Advisory Board
• Responsible for investigating and resolving Level 2 system issues
• Ensures system remains compliance with corporate procedures and multiple regulatory authorities’ requirements

Requirements

• Bachelors degree (e.g. Biology, Statistics, IS/IT) from an accredited institution.
• Minimum of two (2) years of experience or five (5) years of experience working within a GMP/Compliance environment with a focus on data analysis.
• Advanced degree (e.g. MSc, MBA) preferred.
• Experience working with PVWorks, Trackwise or similar validated databases.
• Experience working with databases and database system support.
• Must have Regulatory and/or Compliance experience.
• Demonstrated experience using SQL and SQL Software tools, Qlikview and/or statistical software tools and Crystal Reports.
• Working to develop knowledge of Animal Health Regulatory/Pharmacovigilance laws and guidelines.
• Must have ability to remain calm under pressure and work to meet strict regulatory and customer driven timelines.
• Demonstrates problem solving skills including prioritization, innovation and creativity, managing information from multiple sources both internal and external.
• Must ensure compliance requirements are met for different regulatory authorities worldwide with varying requirements.
• Responsible for advanced system administration activities and escalates to Principal Specialist or Manager of PV Systems if configuration changes are needed.
• Develops new report queries/formats and executes routine reports.
• Supports PV System projects under direction of Principal Specialist and/or PV Systems and Data Analysis Manager.
• Proficiency with Microsoft Office products, specifically advanced graphing in Excel.
• Demonstrated experience with computer systems validation deliverables and change control documentation.
• Excellent oral and written communication skills and an ability to operate effectively in a global and team environments and to build consensus.
• Attention to detail, quality focused and strong technical and problem solving skills.
• Must have excellent organization and time management skills.
• Ability to manage conflict and provide solutions to balance business needs with user friendliness.
• Ability to think and work creatively and independently, under pressure, demonstrating initiative and flexibility.