1+ months

Manager, Lab Systems Compliance and Clinical Data Integrity, Vaccines

Pearl River, NY 10965
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**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 throughnew ideasand 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.



+ Bachelor's Degree inComputer Science, Information Systems, Quality Systems, or Life Sciences

+ Minimum 5 years ofexperience supporting technical aspects of validating quality systems, laboratory systems or computer systems in a regulated industry setting (e.g., 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).


+ Master's degree in a related discipline

+ Experience designing, developing and creating reports, and/or querying one or more database architectures such as Oracle or MS SQL

+ Experience developingbiological assays.

+ Experience working with outside laboratories and establishing data exchanges

+ Experience with various programming languages, web developmenttechnologies, computer architecture and/or algorithms such as Java, R Shiny.


Eligible for Relocation Package

Eligible for Employee Referral Bonus


**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

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.

Information & Business Tech
Posted: 2022-03-25 Expires: 2022-07-11
Sponsored by:
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Manager, Lab Systems Compliance and Clinical Data Integrity, Vaccines

Pearl River, NY 10965

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