What are the responsibilities and job description for the Quality Systems Manager position at Stark Pharma Solutions Inc?
Hi,
My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Quality Systems Manager position. Please send me your updated resume if you have relevant experience and are interested in this opportunity.
Job Title : Quality Systems Manager
Location: North Chicago, IL
Duration: Long Term
Position Overview
We are seeking an experienced Quality Systems Manager to provide quality assurance support within a regulated pharmaceutical manufacturing environment. This role is responsible for ensuring compliance with corporate quality standards, FDA regulations, and industry requirements while driving supplier quality initiatives and strategic quality system improvements.
The ideal candidate will have strong experience in supplier quality management, quality systems, SAP, and quality agreements, with the ability to collaborate across cross-functional teams to support operational excellence and regulatory compliance.
Key Responsibilities
Prepare and maintain supplier quality scorecards and performance metrics.
Track, analyze, and trend supplier quality data to identify improvement opportunities.
Develop, review, and manage Supplier Quality Agreements.
Support Supplier Controls and supplier quality management activities.
Ensure compliance with GMP, FDA, corporate, and governmental quality standards throughout manufacturing operations.
Support quality functions including Document Control, Device QA, Labeling, Validation, Training, and Quality Intelligence.
Collaborate with Manufacturing, Validation, Regulatory Affairs, and cross-functional teams to achieve business objectives.
Utilize SAP and Quality Management Systems to support quality operations, reporting, and compliance activities.
Translate quality strategies into tactical execution while ensuring adherence to regulatory requirements.
Ensure product, process, and system quality activities from raw material inspection through final product shipment comply with corporate and governmental regulations.
Required Qualifications
Bachelor's Degree in Life Sciences or a related field.
8 years of Quality experience within the pharmaceutical, medical device, biologics, cosmetics, combination products, or other regulated manufacturing industry.
Strong experience in Supplier Quality Management, Supplier Controls, and Quality Management Systems (QMS).
Experience preparing supplier scorecards and tracking/trending supplier quality performance.
Hands-on experience creating and managing Supplier Quality Agreements.
Working knowledge of SAP; experience with OneTrack/SolTRAQs and Veeva Vault is a plus.
ASQ Certification is preferred.
Experience supporting Document Control, Device QA, Labeling, Validation, Training, or Quality Intelligence functions is an advantage.
Strong understanding of GMP, FDA regulations, quality systems, and continuous improvement methodologies.
Excellent written and verbal communication skills.
Experience working in pharmaceutical or medical device manufacturing environments.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with your best contact number and the best time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/
My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Quality Systems Manager position. Please send me your updated resume if you have relevant experience and are interested in this opportunity.
Job Title : Quality Systems Manager
Location: North Chicago, IL
Duration: Long Term
Position Overview
We are seeking an experienced Quality Systems Manager to provide quality assurance support within a regulated pharmaceutical manufacturing environment. This role is responsible for ensuring compliance with corporate quality standards, FDA regulations, and industry requirements while driving supplier quality initiatives and strategic quality system improvements.
The ideal candidate will have strong experience in supplier quality management, quality systems, SAP, and quality agreements, with the ability to collaborate across cross-functional teams to support operational excellence and regulatory compliance.
Key Responsibilities
Prepare and maintain supplier quality scorecards and performance metrics.
Track, analyze, and trend supplier quality data to identify improvement opportunities.
Develop, review, and manage Supplier Quality Agreements.
Support Supplier Controls and supplier quality management activities.
Ensure compliance with GMP, FDA, corporate, and governmental quality standards throughout manufacturing operations.
Support quality functions including Document Control, Device QA, Labeling, Validation, Training, and Quality Intelligence.
Collaborate with Manufacturing, Validation, Regulatory Affairs, and cross-functional teams to achieve business objectives.
Utilize SAP and Quality Management Systems to support quality operations, reporting, and compliance activities.
Translate quality strategies into tactical execution while ensuring adherence to regulatory requirements.
Ensure product, process, and system quality activities from raw material inspection through final product shipment comply with corporate and governmental regulations.
Required Qualifications
Bachelor's Degree in Life Sciences or a related field.
8 years of Quality experience within the pharmaceutical, medical device, biologics, cosmetics, combination products, or other regulated manufacturing industry.
Strong experience in Supplier Quality Management, Supplier Controls, and Quality Management Systems (QMS).
Experience preparing supplier scorecards and tracking/trending supplier quality performance.
Hands-on experience creating and managing Supplier Quality Agreements.
Working knowledge of SAP; experience with OneTrack/SolTRAQs and Veeva Vault is a plus.
ASQ Certification is preferred.
Experience supporting Document Control, Device QA, Labeling, Validation, Training, or Quality Intelligence functions is an advantage.
Strong understanding of GMP, FDA regulations, quality systems, and continuous improvement methodologies.
Excellent written and verbal communication skills.
Experience working in pharmaceutical or medical device manufacturing environments.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with your best contact number and the best time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/