Manager, Lab Systems Compliance and Clinical Data Integrity, Vaccines
- Pfizer Inc.
- Location: Pearl River, NY
- Job Number: 7114481 (Ref #: 4868844)
- Posting Date: Oct 24, 2022
- Application Deadline: Open Until Filled
Job Description
Why Patients Need You
We live in a world of fast knowledge creation supported by technology platforms. Pfizer’s digital and ‘data first’ strategy looks to accelerate the delivery of impactful technology solutions for research, development and medical functions. We also look to constantly improve our skills by collaboration and information sharing through business technology to help employees find the best healthcare solutions for our patients. You will be working with a team of innovators who keep our systems up and running as well as our information secure. We need dedicated colleagues like you to enhance patients’ quality of care through new ideas and innovative information technology solutions.
What You Will Achieve
You will leverage your experience in informatics and compliance to develop new and enhance existing data integrity and compliance processes within the organization. You will support all aspects of the existing data integrity and compliance framework. You will work collaboratively across cross-functional teams to set standards for data integrity and compliance. You will work collaboratively on larger projects to collect requirements (business analysis) and test systems (validation engineering) as per the Systems Development Life Cycle (SDLC).
You will work a hybrid work schedule—both on-site and remotely. You will take day-to-day direction from the Senior Manager Informatics Validation and Compliance and other senior leaders within the informatics team and will be expected to work independently most of the time. You will deliver results for milestones associated with large scale projects, train colleagues within the organization on compliance processes. With your passion for innovation, you will employ continuous improvement strategies to improve the performance existing compliance and oversight processes.
How You Will Achieve It
Partner with Informatics Operations Analysts, Architects and Developers/Engineering leads to ensure Vaccines Research and Development information system landscape meets short-term and long-term needs.
Ensure compliant processes exist, and follow those processes, for data collection on instruments and that validated processes exist for non-standard systems.
Ensure compliance related projects are properly established and deadlines communicated.
Collaborate to collect requirements (business analysis) and test systems (validation engineering) as per SDLC.
Effectively lead transitions between various stakeholders to shepherd projects to completion.
Identify performance gaps in information systems and investigate new areas for improvements. For example, in developing new solutions for collecting instrument meta-data and validation state.
Provide operational metrics around various support activities and projects.
Participate and lead where appropriate in the validation of computer systems, instrument qualifications, or hardware processes.
Write departmental SOPs; maintain technical paperwork and migrate such data to archive repository.
Maintain highest minimum compliance required by regulatory standards and mentor any junior team members.
QUALIFICATIONS
Must-Have
Bachelor's Degree in Computer Science, Information Systems, Quality Systems, or Life Sciences with a minimum 5+ years of relevant experience, Master's degree with 3+ years of relevant experience, or PhD with 0+ years of relevant experience supporting technical aspects of validating quality systems, laboratory systems or computer systems in a regulated industry setting working under one or more of: GMP, GCLP, or CLIA requirements
Strong working knowledge of laboratory information management systems.
Strong verbal and written communication skills.
Advanced Microsoft Office Suite skills and strong competency with one or more tools such as Macros, VBA scripting, pivot tables, and V Lookups
Experience with SDLC and regulated documentation (beginning-to-end).
Nice-to-Have
Experience designing, developing and creating reports, and/or querying one or more database architectures such as Oracle or MS SQL
Experience developing biological assays.
Experience working with outside laboratories and establishing data exchanges
Experience with various programming languages, web development technologies, computer architecture and/or algorithms such as Java, R Shiny.
OTHER INFORMATION
Work Location Assignment: Flexible
Other Job Details:
Eligible for relocation package
Eligible for employee referral bonus
We live in a world of fast knowledge creation supported by technology platforms. Pfizer’s digital and ‘data first’ strategy looks to accelerate the delivery of impactful technology solutions for research, development and medical functions. We also look to constantly improve our skills by collaboration and information sharing through business technology to help employees find the best healthcare solutions for our patients. You will be working with a team of innovators who keep our systems up and running as well as our information secure. We need dedicated colleagues like you to enhance patients’ quality of care through new ideas and innovative information technology solutions.
What You Will Achieve
You will leverage your experience in informatics and compliance to develop new and enhance existing data integrity and compliance processes within the organization. You will support all aspects of the existing data integrity and compliance framework. You will work collaboratively across cross-functional teams to set standards for data integrity and compliance. You will work collaboratively on larger projects to collect requirements (business analysis) and test systems (validation engineering) as per the Systems Development Life Cycle (SDLC).
You will work a hybrid work schedule—both on-site and remotely. You will take day-to-day direction from the Senior Manager Informatics Validation and Compliance and other senior leaders within the informatics team and will be expected to work independently most of the time. You will deliver results for milestones associated with large scale projects, train colleagues within the organization on compliance processes. With your passion for innovation, you will employ continuous improvement strategies to improve the performance existing compliance and oversight processes.
How You Will Achieve It
Partner with Informatics Operations Analysts, Architects and Developers/Engineering leads to ensure Vaccines Research and Development information system landscape meets short-term and long-term needs.
Ensure compliant processes exist, and follow those processes, for data collection on instruments and that validated processes exist for non-standard systems.
Ensure compliance related projects are properly established and deadlines communicated.
Collaborate to collect requirements (business analysis) and test systems (validation engineering) as per SDLC.
Effectively lead transitions between various stakeholders to shepherd projects to completion.
Identify performance gaps in information systems and investigate new areas for improvements. For example, in developing new solutions for collecting instrument meta-data and validation state.
Provide operational metrics around various support activities and projects.
Participate and lead where appropriate in the validation of computer systems, instrument qualifications, or hardware processes.
Write departmental SOPs; maintain technical paperwork and migrate such data to archive repository.
Maintain highest minimum compliance required by regulatory standards and mentor any junior team members.
QUALIFICATIONS
Must-Have
Bachelor's Degree in Computer Science, Information Systems, Quality Systems, or Life Sciences with a minimum 5+ years of relevant experience, Master's degree with 3+ years of relevant experience, or PhD with 0+ years of relevant experience supporting technical aspects of validating quality systems, laboratory systems or computer systems in a regulated industry setting working under one or more of: GMP, GCLP, or CLIA requirements
Strong working knowledge of laboratory information management systems.
Strong verbal and written communication skills.
Advanced Microsoft Office Suite skills and strong competency with one or more tools such as Macros, VBA scripting, pivot tables, and V Lookups
Experience with SDLC and regulated documentation (beginning-to-end).
Nice-to-Have
Experience designing, developing and creating reports, and/or querying one or more database architectures such as Oracle or MS SQL
Experience developing biological assays.
Experience working with outside laboratories and establishing data exchanges
Experience with various programming languages, web development technologies, computer architecture and/or algorithms such as Java, R Shiny.
OTHER INFORMATION
Work Location Assignment: Flexible
Other Job Details:
Eligible for relocation package
Eligible for employee referral bonus
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
