Product Complaints Manager
Product Complaints Manager
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$ 102900 - 171500
1 Vacancy
Job Description
Use Your Power for Purpose
The Product Complaints Manager is responsible for leading the Investigators Complaint Analyst and Quality Engineer on the Product Complaint and Regulatory Compliance team. This group consists of 9 exempt individual contributor colleagues.
The key focus of the Product Complaints Manager role is providing effective leadership for the investigation team to ensure timely completion of robust customer complaint internal complaint Retain sample defect and Stability sample defect investigations.
The Product Complaints Manager will also serve as the Local Process Owner (LPO) for complaint processing and investigation at the Rocky Mount focused on maintaining ongoing compliance of all customer complaint internal complaint Retain sample defect and Stability sample defect processing / investigations with cGMP requirements.
Another high priority objective for the Product Complaints Manager role will be to consistently meet or exceed the defined performance metrics for product complaint investigation and Deviation Report (i.e. Internal Complaint Retain sample defect and Stability sample defect) completion / aging.
In addition the Product Complaints Manager will have a Subject Matter Expert (SME) role for complaint Retain sample and Stability sample defect investigations during regulatory inspections.
What You Will Achieve
Responsible for managing processing of customer complaints internal complaints Retain sample defects and Stability sample defects for the Rocky Mount site (e.g. Daily Triage meetings Investigations Status Reports/Extension Requests CAPAs Effectiveness Checks etc. with focus on timely investigation completion / closure.
Facilitate weekly Ad hoc Site Quality Review Team (SQRT) meetings as required for review and discussion of complaint events and other excursion events meeting criteria for elevation to Site Management to determine if further escalation is needed to the Corporate Senior Leadership Team.
Responsible for preparation of slide presentations on Product Complaints performance metrics and key action items for monthly Site Quality Review Team (Quality Management Review) meetings.
Serve as the Local Process Owner (LPO) for product complaint processing at the Rocky Mount site.
Serve as the site Project Lead for any transition of product complaint processing to a new system application.
Support regulatory audits as a Subject Matter Expert (SME) on product complaint processing and investigations.
Assist as needed in the preparation and submission of Executive Summary documents and other documentation required when Complaint events are escalated to the Area Quality Review Team (AQRT) or Enhanced Site Quality Review Team (eSQRT) senior leadership colleagues for review and a final product disposition decision.
Lead continuous improvement activities for the complaints program to ensure efficiency effectiveness and compliance. Promote a continuous improvement culture within the team guiding and coaching direct reports on the use of continuous improvement tools and engaging with business partners to identify areas of improvement across the site.
Emphasize team focus on safety (Star Watch completions) and on time training completion.
Assist as needed in review and responses for Trend Analysis and Trend Notification communications / documentation received from Pfizer Data Analysis and Trending (DAT) for PGS Rocky Mount products.
MDCP complaint metrics tracking trending and presentation to management in MDCP Trend Review Board CAPA Review Board and Quarterly Management Review meetings.
Annual Product Record Review (APRR) completion support as needed.
of Change Control activities as required for the department.
Provide guidance and coaching to team members focused on continuous improvement in investigation / documentation proficiency and completion efficiency.
Provide management oversight to ensure timely completion of the defect samples evaluations for investigation process.
Lead role in communications with representatives from 3rd party (PC1 product customers.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
Excellent written and verbal communication skills with the ability to interact effectively with site colleagues at all levels senior site and above site leadership representatives of 3rd party product customer representatives and regulatory agencies.
High attention to detail and quality / regulatory compliance.
Strong analytical and problemsolving skills.
Good technical writing communication and presentation skills.
Audit presentation / discussion experience.
Excellent computer system skills (MS Word Excel PowerPoint etc..
Experience with electronic documentation control systems.
Experience with electronic investigation processing system (e.g. eQMS).
Knowledge of various quality investigation tools (i.e. DMAIC Cause & Effect Diagrams Is / Is Not analysis 5 Whys 6M Control Charts Human Performance Investigation tools and Risk Management / Analysis).
People management experience is preferred.
PHYSICAL/MENTAL REQUIREMENTS
Office environment primarily. Sitting standing walking ability to perform mathematical calculations and ability to perform complex data analysis.
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Onsite or flex schedule.
Core business hours 85 occasional evening weekend and holiday work may be required.
OTHER JOB DETAILS
Last Date to Apply for Job: April 17 2025.
Work Location Assignment:Onsite
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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.
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 EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Manager
Employment Type
Full-Time
