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Principal Scientist: ARD Compliance Lead


Chapel Hill, NC
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Job Details

Job Title Principal Scientist: ARD Compliance Lead

JobID 1046728-1852

Location: Chapel Hill, NC

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

The Principal Scientist will report to the ARD Compliance Director and will support the delivery of the ARD compliance and data integrity strategy. This matrixed role will interface with the multiple ARD functions as well as strategic partners such as QA and PSSM to ensure compliance with applicable procedures and policies and the implementation of a robust data integrity program. The candidate must be able to interact effectively with highly interdisciplinary teams, in a cross functional environment.


The purpose of this position is to ensure a strong compliance culture and maintain processes to drive high standards of data integrity, quality, and compliance. The candidate will proactively drive departmental initiatives to enhance the overall Quality culture and continue the development and implementation of the data integrity strategies across ARD. The candidate will liaise with appropriate departments, functions and SMEs regarding compliance and data integrity related programs, questions, and communications. This role will also focus on compliance with applicable SOPs, policies, and compliance. This role could also include investigations authoring point of contact/author, CAPA management, QTS support, vendor support, ARD Quality Council representation, instrument validation lifecycle support, and other compliance responsibilities to enhance the overall Quality Culture within ARD and drive compliance and quality standards. Accountability for continuous improvement initiatives for the ARD organization in areas such as data review, specification review and approval, ARD project team interfaces with GMP functions and data integrity initiatives are important for this role. The role will also assist teams in continuous improvement efforts at the interface of ARD laboratory quality systems and bridging technical needs with quality requirements.


EDUCATION:MINIMUM: B.A. / B.S.. in biology, biochemistry, immunology, molecular biology, or related field EXPERIENCE: MINIMUM: Five to 10 years of experience with interdisciplinary drug development teams and industrial experience developing release and stability assays to assess the quality and characteristics of biotherapeutic drug candidates. Significant experience with data integrity approaches and strategy is required. Experience working in a regulated environment (e.g. GLP, cGMP). Proven record of strong technical skills and scientific expertise in assay development and troubleshooting. Proven record of delivering results in a fast paced environment and effective communication to project teams and external partners (e.g. regulatory authorities). Demonstrated technical writing skills. Outstanding leader behaviors and the ability to collaborate with and mentor others is a must.DESIRABLE: Direct experience working with FDA or European regulatory authorities. Experience in GMP environment and implementation of continuous improvement practices. OTHER ATTRIBUTES DESIRABLE:*Comfortable and effective in a team-based, fast-paced environment where multi-tasking required*A record of external presentations (oral, poster and/or publications) in relevant field*Verbal and written communication skills*Awareness of scientific literaturePHYSICAL/MENTAL REQUIREMENTS Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Occasional travel may be necessary.

*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.

*Principal Scientist: ARD Compliance Lead*
*Chapel Hill, North Carolina*

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