Pfizer Quality Manager in McPherson, Kansas
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 314.81 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 ROLE SUMMARY
Quality Assurance Manager is the site process owner for Field Alert Reporting and the Area Quality Review Team processes owner at the McPherson Site. This role owns training and process enhancement activities for both processes. This position is a key participant in the daily triage and prioritization of product complaints, manufacturing and laboratory investigations to ensure escalation to management of information regarding the need for field alert reporting to ensure decisions are made in a timely manner. This role is responsible to ensure escalation of issues that require Senior Management decision for field alert reporting, the prioritization of AQRT issues, meeting the timing requirements for submission of FARs and reporting of FAR and AQRT metrics during management review. This role works closely with all investigation groups to ensure the investigations are progressing within the timeline needed for the FAR and AQRT processes. They ensure the investigations and field alert reporting processes are performed in accordance cGMP expectations. Additionally, they will be the single point of contact at the site regarding field action processes owned at the site level.
Provides compliance oversight for all product complaint, manufacturing and laboratory 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, laboratory 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 and other types of investigations being performed at Pfizer 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 Pfizer awareness. Manages the overall Field Alert Notification process at the McPherson site:
Manages the timeline and prioritization of FARs
Prepares and or ensures preparation 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.
Manages (without supervisory authority) the prioritization and timely completion of investigations related to FARs to ensure expected deadlines are met.
Prepares or ensures preparation of Follow up and Final FARs following the completion of root cause investigation within the defined timeframes.
Defines the required participants and performs training to ensure thorough understanding of the FAR process at the site level.
Manages the overall FAR process and performs gap assessments to determine process enhancements to ensure regulatory and internal expectations are met or exceeded.
Ensure accuracy and reporting of FAR metrics at both site and above site level.
Single point of contact for site and above site tracking systems for FAR metrics and any other required information and/or review meetings
Manages the Area Quality Review Team process at the McPherson site:
Prepares the Area Quality Review Team executive summaries.
Requests and manages timing requirements for Health Hazard Assessments as associated with AQRTs.
Prioritizes AQRTs to ensure high-risk/high-impact issues are being addressed in a timely manner.
Manages site prioritization and management escalation meetings regarding AQRTs
Site single point of contact for the AQRT process and above-site prioritization/information management meetings.
Manages (without supervisory authority) the prioritization and timely completion of investigations related to AQRTs to ensure expected deadlines are met.
Defines the required participants and performs training to ensure thorough understanding of the AQRT process at the site level.
Manages the overall AQRT process and performs gap assessments to determine process enhancements to ensure internal expectations are met or exceeded.
Ensure accuracy and reporting of AQRT metrics at both site and above site level.
Single point of contact for site and above site tracking systems for AQRT metrics and any other required information and/or review meetings
Single point of contact regarding any required field actions that result from AQRT decisions.
Provides all required documentation and information needed by above site functions to ensure field action requirements are met.
Responsible for any required action or follow-up information as required by above site functions or regulatory agencies as related to field actions.
Responsible to ensure the appropriate escalation to and/or required reviews by appropriate Senior Management occurs regarding any information requests by external regulatory agencies.
Provides data/presentations 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 2-5 years of experience within Quality.
Strong technical writing skills
Strong interpersonal skills at all levels within the organization
High-level of capability in software/technology highly desireable (i.e. Excel, Word, PowerPoint, Share point, etc.)
High level of organizational skills and independence
Strong judgment and decision making ability
Ability to manage without authority
Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry. Knowledge of device/combination product industry regulations highly desirable.
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.
Additional Offer Details:
Last Date to Apply for Job: April 21, 2018
This job is Pfizer (Exempt) (US/PR) Grade: 18
Relocation Assistance being provided
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.