Pfizer Quality Manager in McPherson, Kansas

SUMMARY:

Quality Field Alert Manager performs a comprehensive review and disposition of the information collected during the investigation of the product complaints in accordance with 21 CFR 211.198. In addition to complaint disposition this position requests written medical assessments from corporate Global Product Safety and submits initial, follow-up and final Field Alert Notifications (FARs) to the FDA in accordance with 21 CFR 314.91 when Hospira becomes aware of any event that may affect marketed drug products manufactured or distributed in the US. This position also assists with the recall process for Hospira McPherson products.

  • Provides compliance oversight for all product complaint and manufacturing investigations relating to Field Alert Report Notifications and Area Quality Review Team executive summaries assuring that thorough root cause evaluations are performed.

  • Collaborates with complaints and manufacturing investigators to ensure the appropriate level of detail is included in the investigation to ensure proper dissemination of information for regulatory reporting.

  • Participates in the triage of all product complaints received at Hospira McPherson to determine if issue escalation, containment actions or if a US FDA Field Alert Notification Form is required. This must be assessed within three (3) days of the Hospira awareness. Prepares initial Field Alert Notification Forms (FARs) based upon the initial analysis of product complaints that indicate the potential that marketed drug products manufactured or distributed in the US are impacted.

  • Prepares Follow up and Final FARs following the completion of root cause investigation.

  • Prepares Area Quality Review Team executive summaries.

  • Initiates recall forms for all McPherson Hospira products recalled.

  • Ensures accuracy of Metric and Tracking information for FARs and AQRTs (Area Quality Review Teams)

  • Ensures accuracy of Center tracking databases regarding FARs and AQRTs. Represents site at weekly AQRT data review meetings.

  • Provides data for preparation of Site Quality Review Team (SQRT)/ad hoc SQRT slides/data for monthly/weekly site meetings

  • Supports and maintains an environment that fosters communication and teamwork within QA and related departments.

  • Perform other duties as assigned by area management.

  • Bachelor's degree required

  • 5-7 years of experience in the FDA regulated industry. Preferably 1-3 years of experience within Quality.

  • Strong technical writing skills

  • Strong interpersonal skills at all levels within the organization

  • High level of organizational skills and independence

  • Strong judgment and decision making ability

  • Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry

Grade: L-HSP 18

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.

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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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