Quality Assurance Manager Job at Stark Pharma Solutions Inc, Illinois

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  • Stark Pharma Solutions Inc
  • Illinois

Job Description

Job Title: Quality Assurance Manager
Location: Waukegan, IL
Experience: 8+ years
Contract Duration: 12+ months with potential extension
Work Authorization: Candidates open to relocation are welcome. Relocation assistance is not provided.

Job Summary

The Quality Assurance Manager is responsible for leading and supporting quality system activities across regulated manufacturing environments. This role ensures compliance with applicable regulatory requirements and internal quality standards across the full product lifecycle, from raw material receipt through final product release and distribution. The position supports both strategic initiatives and hands-on execution of quality system processes within pharmaceutical and or medical device manufacturing.

Key Responsibilities
  • Provide quality assurance leadership and oversight for regulated manufacturing processes, including pharmaceuticals, medical devices, cosmetics, combination products, and biologics as applicable

  • Ensure quality systems align with corporate policies and global regulatory requirements

  • Translate quality strategy into actionable, tactical objectives to support business and compliance goals

  • Lead and support quality system functions such as Document Control, Device Quality Assurance, Labeling, Validation, Training, Supplier Quality, and Quality Intelligence

  • Oversee the development, review, and maintenance of Quality System procedures, work instructions, and process documentation

  • Ensure product, process, and system quality activities comply with FDA, ISO, and other applicable global regulations

  • Manage supplier controls including qualification, monitoring, audits, and performance management

  • Support regulatory inspections, internal audits, and quality system assessments

  • Review and assess quality impact of process changes, deviations, investigations, and CAPAs

  • Collaborate cross-functionally with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain teams

  • Provide guidance and mentorship to quality team members and stakeholders

  • Monitor quality metrics and drive continuous improvement initiatives

Required Qualifications
  • Bachelor's degree in Life Sciences or a related scientific discipline

  • Minimum of 8 years of experience in Quality within pharmaceutical or medical device manufacturing

  • Strong working knowledge of quality systems and regulatory compliance requirements

  • Proven experience writing and maintaining Quality System procedures and process documents

  • Hands-on experience with supplier quality and supplier control processes

  • Excellent written and verbal communication skills

  • Ability to translate regulatory and quality requirements into practical business solutions

  • Experience supporting inspections, audits, and regulatory interactions

Preferred Experience
  • Experience supporting multiple regulated product types

  • Exposure to validation, labeling, and training systems

  • Leadership experience within quality organizations

Job Tags

Contract work, Relocation, Relocation package,

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