Job Description

Job Description

Job Description

Job Title: Quality Project Manager

Location: Metropolitan Area
Job Type: Full-time
Industry: Pharmaceutical / Medical Devices
Experience Required: 5 yrs
Languages: Fluent in English and Spanish

Position Summary:

As a Quality Project Manager (Consultant), you will lead complex, cross-functional investigations and improvement initiatives related to raw material non-conformances (NCRs) within the Manufacturing & Packaging operations for diabetes-related products. This role requires strong leadership, strategic project oversight, and regulatory expertise to drive timely, compliant, and risk-based resolution of quality issues. You will serve as a key advisor and quality representative, collaborating with internal and external stakeholders to mitigate risks, implement corrective and preventive actions (CAPAs), and promote continuous improvement across the supply chain.

Key Responsibilities:

• Lead and manage raw material NCR investigations and quality projects in manufacturing and packaging operations.
• Serve as liaison between internal teams (Quality, Engineering, Production, Procurement) and external suppliers.
• Drive timely implementation of CAPAs, ensuring regulatory and procedural compliance.
• Facilitate root cause analyses (RCA), risk assessments, and improvement action plans.
• Monitor and report key quality metrics and supplier performance trends.
• Present findings to senior leadership and support regulatory audits.
• Identify systemic issues and lead continuous improvement initiatives.

Academic Requirements:

• Bachelor’s degree in Engineering, Chemical Engineering, Mechanical Engineering, Industrial Engineering, or a related engineering discipline.
• A master’s degree is a plus, but not required.

Required Experience:

• Minimum 5 years of experience in regulated industries (pharmaceutical, medical device, or biotechnology).
• Proven experience in quality investigations, deviations, or NCRs related to raw materials.
• Strong knowledge of cGMP, QSR, ISO 9001, ISO 13485, and electronic quality systems (TrackWise, Veeva, MasterControl).
• Fluent in Spanish & English (professional/technical level).
• Experience with supplier quality management and packaging operations.
• Familiarity with ICH guidelines, USP/NF standards, and global regulatory expectations.

Regulatory Knowledge:

• U.S. Regulations:
  • 21 CFR Parts 210, 211, 820 (GMPs and QSR)
  • 21 CFR Part 11 (electronic records and signatures)
• International Standards:
  • ISO 9001, ISO 13485
  • ICH Q7, Q9, Q10
  • USP/NF
  • Familiarity with EMA, Health Canada, or WHO standards is a plus.

Key Competencies:

• Leadership and strategic thinking.
• Advanced problem-solving and risk management.
• Strong project management and organizational skills.
• Effective communication and stakeholder engagement.
• Proficiency in project management tools (MS Project, Smartsheet, JIRA).

Why Join Us?

• Opportunity to work in a regulated and innovation-driven environment
• Collaborative team culture
• Exposure to complex and impactful projects
• Career development opportunities

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