Quality Project Manager

Smart Precise Solutions, Inc.

Juncos, PR
55.000-65.000 USD al año
Permanente
Tiempo completo

Hace 8 días

*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

Job Type: Full-timePay: $55,000.00 - $65,000.00 per yearBenefits:

Health insurance
Life insurance
Paid time off
Referral program

Work Location: In person

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