Analyst IV / Sr. Analyst - Nonclinical Safety Systems

BoehringerPRD•Brampton, ON

7d•$115,000 - $222,000•Hybrid

About The Position

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 several 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. The Analyst IV / Senior Analyst, Nonclinical Safety (NCSUS) Systems provides oversight and management of the Nonclinical Safety (NCS) Laboratory Information Management System (LIMS) global and local computer systems involved in study execution, data collection, reporting, and support activities for NCS. This role is responsible for the adherence to and application of the validation lifecycle to ensure that NCS computer systems are following regulatory requirements and supported by appropriate documentation, training, and monitoring. The incumbent maintains NDS LIMS systems and other assigned GxP systems in a validated state. The Analyst IV / SR Analyst, NCSUS Systems independently designs and manages computer systems validation testing of global and local NCS computerized systems in compliance with Standard Operating Procedures, policies, and international regulations leading to successful implementation and use of those systems and compliance with regulatory requirements. The incumbent is responsible for ensuring that NCS LIMS users, at all levels in the NCS organization regarding system use and regulatory requirements (GLP and Part 11), are trained in the use of the system, which may involve the creation of training programs that meet regulatory requirements. The position holder is a subject matter expert (SME) regarding compliance and quality by implementing operational excellence and quality management programs for the local and global computerized systems used by NCS. As an SME, this role will provide training and mentorship to junior analysts or scientists in the department and works collaboratively within the department and cross-functionally.

Requirements

Requires a Bachelor’s degree with 8 years of pharma experience (or equivalent)
Advanced regulatory knowledge is expected, but typically in the 5–6 year experience range
Computer Validation experience in a regulated environment
Advanced/In-depth knowledge (5-6 years experience) of relevant regulations and guidances; acts as a resource for colleagues.
Bachelor’s degree and/or equivalent with ten-plus (10+) years in validation of computerized systems in a pharma environment.
Computer Validation experience in a regulated environment.
Advanced/In-depth knowledge (ten (10) years of experience) of relevant regulations and guidance.
Onsite/Flex: This position is site based with flexibility for remote working. Working onsite a minimum of 2-3 days per week is required. Remote working norms will be clarified during the interview process.
Computer Validation experience in a regulated environment
Ability to formulate strategies for performing regulated activities based on knowledge of regulations and guidance.
Works independently with minimal supervision or guidance.
Ability to make decisions in assigned area for department in manager’s absence.
Independent problem detection and implementation of problem solution.
Independent representation of department.
Excellent organization skills resulting in the ability to be self-directed and manage multiple cross functional programs and projects.
Ability to effectively work with individuals from diverse perspectives (technical, organizational, level of expertise and cultural).
Ability to effectively communicate (up and down) in verbal and written form; good interpersonal skills
Acts as a resource for colleagues.
Excellent leadership and mentoring skills; ability to influence when no management authority.
Knowledge of process improvement concepts and applications in R&D environment
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

Responsibilities

Leads computer system compliance as the department subject matter expert and provides mentoring and hands-on support to the NDS function in the areas of computer and/or equipment validation and/or qualification by: Leading and managing the project initiation, planning, execution, and release phases.
Providing development, design, and hands-on support through development, review and approval of computer and equipment validation plans, test cases, reports, protocol executions, documentation of test results, procedures, plans, instructions, analysis and interpretation of results and the test discrepancy process.
Providing leadership, management, and hands-on support during maintenance and when the system is released for production (e.g., change controls, deviations, periodic reviews, etc.)
Leading the application of the Risk Based Approach to computer validation activities within functional.
Maintains computerized systems in a validated state.
Identifies compliance gaps in computer and/or equipment validation and/or qualification and participates in the implementation of process improvements related to computer and/or equipment validation and/or qualification across Development.
Reports findings to NDS management as necessary.
Proposes, evaluates and implements new technologies.
Independently applies basic scientific principles.
Performs literature searches, attends scientific meetings, and keeps abreast of literature in own field.
Maintains current knowledge of developing regulatory changes.
When required or appropriate, attends as a respondent to inspections and audits by regulatory agencies, BI compliance groups, and consultants in area of responsibility.
Leads investigations to assign CAPA and resolve complex observations noted during audits / inspections.
Leads and organizes inspection readiness activities related to computerized systems.
Functions as an acknowledged resource within and outside the department with respect to computerized system validation.
Maintains expert proficiency in technical skills and regulatory compliance issues through industry contacts, journal articles, professional and user group meetings and seminars.
Works collaboratively within the department and globally with colleagues from NDS, Animal Resources, Quality, and IT; with other Validation Managers and Application Administrators; with SMEs responsible for software and/or instrumentation; and with external software providers.
Trains new personnel as required and develops and implements training programs in the technical and regulatory requirements as requested.
Is a resource for colleagues with less experience and mentor to junior analysts/scientists.