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Pfizer Inc

Data Integrity Manager

Pfizer Inc - Saint Louis, MO

**ROLE SUMMARY**

The Data Integrity Manager will assume a new role at the Site to project manage data integrity remediation efforts in the short term, and then construct, exercise, and continuously improve sustainable best practices for a data integrity program at the St. Louis Site. This role will require tactical skills in support of technical system risk management and remediation (computerized lab, production, and enterprise systems) and project management, as well as strategic capability in the form of program development and ownership (including policies, procedures, leading governance and quality performance monitoring efforts, etc.).

**ROLE RESPONSIBILITIES**

Oversight of the St. Louis Site's Data Integrity Quality System, including development and leadership of appropriate governance, development and institution of requisite policies and procedures, establishment of sustainable and effective means of quality performance monitoring, and training of Site colleagues on the principles of data integrity.

Project Management accountability for the coordination of efforts amongst Pfizer colleagues and contractors as they perform remediation activities to sustain data integrity requirements for compliant computerized and paper based systems. Project management accountability will include scheduling, monitoring and reporting progress to management, and facilitation of option analyses and selection of gap assessment remediation options.

Integration of data integrity requirements, philosophy, and best-practices into the computerized system validation lifecycles for quality control instruments, manufacturing production and data analysis systems, and local instances of enterprise systems.

Lead cross-disciplinary efforts and teams to build, establish, and continually strengthen the quality systems linkages between the Data Integrity Program and Pfizer's other Quality Systems.

Serve as the primary Point of Contact (POC) at the St. Louis Site with respect to Pfizer's network/multi-site data integrity initiatives and teams, as serve as first-line POC for St. Louis's Data Integrity Program during audits and regulatory inspections.

Quality Subject matter Expert (SME) for Data Integrity

Maintain contemporary knowledge of regulatory requirements, and industry trends, and enforcement actions to ensure that Pfizer maintains a best-in-class Data Integrity Program.

Develop validation plans and risk management plans including traceability analysis. Participate in higher level validation activities, specifically around development of test scripts and other GxP documentation generated during system support and validation.

Ensure Compliance of Data integrity within Quality System through Periodic Review of Manufacturing and Laboratory operations.

Perform unannounced data integrity surveillance audits

Should participate in the investigation and corrective action for reported improper practice

Evaluate applicable corrective and preventive action (CAPA) responses to the assessment findings for adequacy and timelines.

Provide feedback to management on periodic basis in relation to overall compliance on data integrity.

Review Standard Operation Procedure (SOPs), audit reports, audit schedules/plans, and other documentation as required.

Independently drive change management processes for routine changes

Support other functions, other duties within the quality department as required.

**QUALIFICATIONS**

Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum of four years related experience or equivalent combination of education and experience

Minimum seven (7) years of experience in a pharmaceutical production, device manufacturing, or laboratory environment.

Experience in current Good Manufacturing, 21 CFR Part 11 regulations, Good Documentation Practices, and other applicable regulations for validated computerized systems required.

Must have strong inter-personal skills, ability to manage projects, must learn quickly, must be intuitive, self-reliant, and possess excellent analytical skills and leadership ability.

Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.

Knowledge of MS Office Suite is required.

Fluent in English both speaking & writing.

Experience in Quality Systems in pharmaceutical, medical device, or combination product industry preferred.

Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) preferred.

Experience in aseptic manufacturing is preferable.

**PHYSICAL/MENTAL REQUIREMENTS**

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise.

Work independently, with minimal supervision, under strict time guidelines; Stress (system owners/users expect immediate attention to and resolution of problems); Flexibility/organizational skills; speed and dexterity required.

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

Controlled Laboratory, Production and Warehouse environments requiring safety glasses, lab coats, steel-toed shoes and gloves (as applicable) be worn at all times.

Must be willing and able to work beyond the hours typically defined as a regular workday, which may or may not include weekends and holidays.

Travel between Brentwood and Westport locations required.

**EEO & Employment Eligibility** (KING SITES ONLY)

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.

This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.

**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.

**Other Job Details:**

**Last Date to Apply for Job: 1/26/2018**

Eligible for Relocation Package - Yes

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

5 days 9 hours ago

Pfizer Inc

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Data Integrity Manager Pfizer Inc - Saint Louis, MO, United States

   

Location: Saint Louis, MO

Company Profile:
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.