|Location:||Ridgefield, CT (06877)|
|Job Type:||Full Time|
|Posted:||6 days ago|
Responsible for IT Quality & Compliance tasks to ensure efficient and effective common IT regulations and IT Quality Management processes/systems are in place and are monitored within the global IT function, and to drive IT compliance with legal and regulatory requirements as well as with corporate compliance policies where applicable in the IT arena (eg Cloud Computing, segregation of duties). Support overall Quality oversight and CAPA tracking in IT function.
IT Quality Management\:
Compliance sign off for SLC activities related to IT infrastructure qualification and validation of application systems used in IT (eg change control, risk assessment, configuration and installation testing, functional and requirement testing, periodic review, exception monitoring, etc.) thus ensuring all deliverables meet regulatory requirements, including computer systems validation, electronic records, data integrity and signature requirements
Ensure implementation and monitoring of effective and efficient quality related IT processes (eg during Self-Inspections)
Communication with global Quality and Compliance business functions and for meeting business quality and compliance needs
Ensure compliance with legal and regulatory requirements, and corporate compliance policies
Foster a culture of quality and compliance within the IT Function
Provide compliance trainings (GxP and non-GxP) and therefore ensure awareness and communication to IT personnel
Contribute to continuously improve the level of quality within IT Function
Create, review and update Corporate IT Regulations (Policies/Procedures/SOPs/Working Instructions) and monitor adherence to those
Improve the Corporate IT Quality Management System continuously based on legal regulations and quality targets (eg by creating and/or reviewing of global/local SOPs/Working Instructions), eliminate unrewarded complexity and improve efficiency
Audits, Self-Inspections & IT Supplier Audits/Assessments
Coordinate and support Corporate IT related external and internal audits/inspections (eg by authorities or third parties)
Conduct IT quality assessments/self-inspections and vendor audits according to plan
Monitor and assess effectiveness of CAPA measures implemented
IT Q&C Consulting\:
Perform proactive, effective consulting and coaching to support validation/qualification activities
Contribute to global/local projects based on time, cost and quality targets
Contribute to global/local Working Groups to continuously improve the level of quality within Corporate IT
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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees
Duties & Responsibilities\:
Ensure compliance of quality deliverables for computer systems and services related to IT infrastructure qualification thru
Compliance sign off on SLC activities related to IT infrastructure qualification and validation of application systems supporting IT processes
Quality oversight on external IT infrastructure service provider
Create, review and update global IT regulations (Corporate IT SOPs/Working Instructions) for IT Quality Management System (GxP/non-GxP);
Quality Management\: Manage deviation and CAPA process, key contact for GoTrack in the Americas region. Ensure that deviations and CAPAs are accurately entered and tracked in the GoTrack system. Provide assistance and feedback it IT employees regarding creating deviations and CAPAs where applicable.
Audits, Internal and Vendor Assessments\: Coordinates audits (CDIA, Corporate QA etc.), and internal assessments as per the IT Audit Framework, prepares IT employees for audit engagement through training exercises. Acts as lead auditor and/or coordinates and/or conducts external quality assessments of potential partners/service providers (eg SaaS) in the region Americas.
Training\: Coordinate training needs for the IT organization globally. Ensure training needs of the IT organization are being met, particularly GxP related topics. Identify, develop and deliver training to the IT organization as required.
Bachelor's degree from an accredited institution in Computer Science or related field with minimum nine (9) years of experience; or a Master's degree from an accredited institution in Computer Science, MIS, or related field with minimum seven (7) years of experience; or relevant Business or IT experience of minimum of eleven (11) years.
Experience in a quality management and or regulatory compliance role highly desirable.
Extensive knowledge of the regulated environment (eg GxP, audits) and Information Technology
Multi-year experience with quality management systems (eg GAMP) and IT standards (eg ITIL)
Strong communications skills, analytical thinking, relationship management
Ability to build consensus and influence decisions.
Work experience in global business environment
Willingness to travel abroad
Apply IT risk management process and monitor adherence;
Ensure IT compliance with legal and regulatory requirements also outside GxP arena (eg Accounting, Corporate Compliance)
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
This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
Who We Are\:
At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.