regional quality assurance manager in philadelphia

posted
contact
terri miniutti, tatum executive services
job type
permanent
salary
US$ 85,000 - US$ 100,000 per year
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job details

posted
location
philadelphia, pennsylvania
job category
Warehousing & Distribution
job type
permanent
working hours
8 to 5
salary
US$ 85,000 - US$ 100,000 per year
experience
7 Years
reference number
496687
contact
terri miniutti, tatum executive services
phone
612-313-7941

job description

job summary:

Quality Assurance Manager

High volume U.S -based Global Solutions provider with corporate- owned branches world-wide, has a key opportunity in Philadelphia for their Quality- Pharmaceutical / Life Sciences Sector. This role will support the Philadelphia Facility, and will be the Subject Matter Expert in issues concerning quality, regulations, and shipment of goods worldwide.

The QA Manager is responsible for the implementation of the Quality processes, procedures and policies required to manage and control facility in Philadelphia to ensure compliance with Good Manufacturing and Distribution Practices (GMDP) and national/ international regulations and requirements.

 
location: Philadelphia, Pennsylvania
job type: Permanent
salary: $85,000 - 100,000 per year
work hours: 8 to 5
education: Bachelor's degree
experience: 7 Years
 
responsibilities:
  • Implement, communicate and maintain Quality System and policies
  • Define standards and quality processes and procedures throughout effective controlled documents
  • Write quality assurance procedures as required for GMDP compliance
  • Write quality assurance procedures as required for GMDP compliance
  • Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated CAPA - Corrective and Preventive Actions
  • Oversee and review quality issue reporting, resolution and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  • Prepare an external audit program and perform audits of external service providers as part of the vendor's selection process;
  • Host client audits and regulatory inspections and manage the audit report responses;
  • Manage CAPA plans up completion and effectiveness and implement quality improvements initiatives;
  • Ensure the local implementation of Technical Quality Agreements and compliance with requirements described into the documents;
  • Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  • Maintain general Quality, Health and Safety standards within the branch
  • Define and execute training to improve understanding of and compliance with procedures and quality requirements
 
qualifications:

.

  • Bachelor's degree or the equivalent combination of relevant education and professional experience.
  • 5+ Years of relevant experience. Quality and Logistics experience preferred
  • Experience working in a GMP and GDP environment. Experience in the Pharmaceutical Sector is preferred
  • Senior or Lead Auditor experience in self inspections, internal and external audits
  • Experience from working in a compliance role, ideally with exposure to GDP and QMS environment
  • Experience in driving the daily workload and performance based on data (shipment/milestone reports, KPI matrix etc)
  • Experience with airfreight operations, import/export operations and related regulatory requirements (TSA, US CBP, FDA etc)
  • Driving win-win outcomes in situations of conflict, escalations and customer complaints
  • Skilled trainer
  • Experience in driving the daily workload and performance based on data and performance KPIs (shipment/milestone reports, KPI matrix etc)
  • Expertise skills in defining and writing procedures and work instructions
  • Structured and solution driven

COMPANY BENEFITS:

This company is one of the largest suppliers of supply chain solutions in the world. Excellent compensation plan including base salary, bonus, exceptional Medical/Dental,Vision insurance, 401K, Tuition Reimbursement, Paid Holidays, etc.

 
skills: Vendor Relations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

skills

Vendor Relations

qualification

.

  • Bachelor’s degree or the equivalent combination of relevant education and professional experience.
  • 5+ Years of relevant experience. Quality and Logistics experience preferred
  • Experience working in a GMP and GDP environment.   Experience in the Pharmaceutical Sector is preferred
  • Senior or Lead Auditor experience in self inspections, internal and external audits
  • Experience from working in a compliance role, ideally with exposure to GDP and QMS environment
  • Experience in driving the daily workload and performance based on data (shipment/milestone reports, KPI matrix etc)
  • Experience with airfreight operations, import/export operations and related regulatory requirements (TSA, US CBP, FDA etc)
  • Driving win-win outcomes in situations of conflict, escalations and customer complaints
  • Skilled trainer
  • Experience in driving the daily workload and performance based on data and performance KPIs (shipment/milestone reports, KPI matrix etc)
  • Expertise skills in defining and writing procedures and work instructions
  • Structured and solution driven 

COMPANY BENEFITS:  

This company is one of the largest suppliers of supply chain solutions in the world.  Excellent compensation plan  including base salary, bonus, exceptional Medical/Dental,Vision insurance, 401K, Tuition Reimbursement, Paid Holidays, etc.

responsibilities

  • Implement, communicate and maintain Quality System and policies
  • Define standards and quality processes and procedures throughout effective controlled documents
  • Write quality assurance procedures as required for GMDP compliance
  • Write quality assurance procedures as required for GMDP compliance
  • Prepare an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated CAPA - Corrective and Preventive Actions
  • Oversee and review quality issue reporting, resolution  and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  • Prepare an external audit program and perform audits of external service providers as part of the vendor’s selection process;
  • Host client audits and regulatory inspections and manage the audit report responses;
  • Manage CAPA plans up completion and effectiveness and implement quality improvements initiatives;
  • Ensure the local implementation of Technical Quality Agreements and compliance with requirements described into the documents;
  • Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  • Maintain general Quality, Health and Safety standards within the branch
  • Define and execute training to improve understanding of and compliance with procedures and quality requirements

educational requirements

Bachelor's degree