Pfizer Sr. QO Position in Franklin, Ohio
Accountable for the Supplier Management System including planning and conducting supplier audits, managing supplier Quality agreements, issue resolution and troubleshooting to assure procurements meet or exceed the requirements. Conducts programs designed to improve supplier performance, productivity, and process validation. Prepares, maintains and reviews procurement quality assurance procedures to assure compliance with customer and/or government requirements. Manage the Site Readiness Program. May also audit third party manufacturers, due diligence and vendor selection process.
Regulatory Compliance Support:
Responsible for managing Internal audit program. Supporting regulatory inspection. Responsible for activities involved in Quality oversight for change control system/product CMC change control oversight with Regulatory Affairs, APR program management, QA support for non-manufacturing functions/activities, and quality performance metrics/quality dashboard. Also typically provides Quality oversight for the following functions found under separate Job Families: 'Documentation' Management, and 'QA for Computer Systems'.
May be responsible for activities involved in writing, review and approval of the validation procedures, protocols, validation master plan and evaluating quality process and system standards to ensure compliance with Pfizer Quality Standards and governmental regulatory requirements.
Responsible, among other things for:
Interface to the sites' suppliers
Plan and conduct supplier audits
Plan and conduct Quality Review Meeting with suppliers
Maintain the SMS system
Manage supplier Quality Agreements
Manage Internal Audit Program
Support Regulatory Inspections
Administration of Site Inspection Readiness Program including Internal Quality Assessments and Data Integrity Program
Evaluation and Completion of RONA Reports
Preparation of Annual Product Reports (APR/PQR)
Manage Regulatory queries and responses
Manage Regulatory Change Controls for permanent changes.
Other activities as identified by the supervisor
- BS/BA with at least 5 years of experience as Quality professional
MS/MA with at least 8 years of experience as Quality professional
Strong Experience leading a Supplier Management System
Accountable for adhering to Pfizer standards, guidelines and values
Must be detail oriented and able to make sound decisions. Proactively identifies and resolves potential problems with basic complexity. Working knowledge of cGMP with high productivity and ability to multi-task coupled with a low error rate.
Good oral, and written communications skills and computer literacy
Manages own time and professional development; accountable for own results. Work is performed under broad guidelines and with limited supervision. Ensures completion of any team assignments
Identifies and implements processes to improve performance and increase efficiency, consciously balancing the risk and reward trade-off
While performing the duties of this job, the employee is exposed to general laboratory and/or manufacturing areas; work near moving mechanical parts; toxic or caustic chemicals; the noise level in the work environment is usually moderate; required to stand; walk; sit; talk or hear; must occasionally lift and /or move up to 25 pounds; specific vision abilities require by this job include ability to adjust focus
Position requires regular onsite attendance, this position cannot be performed on a remote / telecommute basis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements
Must have the ability to work effectively under and manage to strict production, time and performance deadlines
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
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued
No Relocation eligible
Routine interaction with Site' colleagues (Production, Quality Control, Technical Services, Site Services and Site Leadership Team) and Global Suppliers
Periodic interaction with other Pfizer colleagues ( Other Sites, GCMC, COQA, MSQA, BT, PCONE)
Sporadic interaction with other site customer and regulatory agency representatives
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.
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: September 25, 2018
Additional Location Information: Franklin, OH
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.