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Manager, Computer Systems Validation


Pearl River, NY
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Job Details

Job Title Manager, Computer Systems Validation

JobID 1051592

Location: Pearl River, NY

Description This is a Quality Assurance role that is primarily responsible for supporting the operations and deployment of Enterprise Business Technology (BT) supported Computer Systems. This role is responsible for ensuring that enterprise computer systems System LifeCycle Documents (SDLC) meet regulatory and Pfizer compliance requirements across GMP R&D sites.

• Review and approve System Development Life Cycle (SDLC) documentation, investigations and change controls related to enterprise Business Technology (BT) supported computer systems.

• Support the Quality Assurance collaboration tools and infopath forms.

• Responsible to liaison with Pfizer commercial manufacturing sites to ensure harmonization of validation practices.

• Review and approve procedures related to enterprise BT supported computer systems.

• Act as the QA liaison/oversight/authority for the business lines, support groups and BT

• Lead or participate on special projects, teams and internal or external global initiatives.

• Support site-based and global activities including Boards of Health inspections and corporate audits.

• Performs job responsibilities in compliance with cGMP and all other regulatory agency requirements.

Basic Qualifications

BS/BA with 2+ years QA experience or relevant experience in clinical quality management, biomedical science, clinical development, or regulatory strategy

• Strong experience and knowledge of computer systems validation practices and regulatory requirements, Including GAMP 5 and CFR Part 11.

• Strong experience and knowledge of System Development Life Cycle methodology and requirements.

• Experience and understanding to align business processes with technical solutions.

• Good understanding of IT systems (applications and infrastructure).

• Functional and technical knowledge and skills to do the job at a high level of accomplishment

• Proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities

• Proven ability to function autonomously in a matrix model and in a team environment

• Proven business management capability

• Proven ability to think creatively and to execute and manage strategic plans

• Logic and analytical skills - Uses rigorous logic and methods to solve difficult problems with effective solutions. Probes all sources for answers; can identify hidden problems and is excellent at analysis. Goes beyond the obvious and seeks novel approaches to complex situations.

Pfizer Exempt US/PR Grade: 010

Additional Location Information: Andover MA, Groton CT, Lake Forest IL, Chapel Hill, NC, St. Louis

No Relocation Available

Eligible for Employee Referral Bonus

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.

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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