Quality Lead

Job Summary

We are seeking an experienced Quality Lead for a direct hire opportunity in Cayey, PR within the pharmaceutical manufacturing industry. This role is ideal for a quality professional who is ready to operate at a strategic leadership level, guiding quality systems, regulatory compliance, audit readiness, and continuous improvement across manufacturing operations.

The Quality Lead will provide direction and oversight for the Quality function, ensuring compliance with FDA regulations, ISO standards, corporate quality requirements, and internal quality programs. This position offers the opportunity to work in a highly regulated, quality-focused environment where collaboration, accountability, and continuous improvement are valued.

This is a strong opportunity for a candidate who enjoys cross-functional leadership, regulatory interaction, process improvement, and building a culture of quality. The role partners closely with Operations, Engineering, Product Development, and leadership teams to strengthen manufacturing performance, improve product quality, and support long-term operational success.

Key Responsibilities

- Establish and drive quality strategy aligned with FDA regulations, ISO standards, corporate policies, and the Product Quality Rating System.
- Lead quality oversight for new process implementations, machinery Quality Acceptance Tests, Zero Production acceptance protocols, and manufacturing readiness activities.
- Serve as a primary Quality representative during FDA inspections, audits, and regulatory interactions, including preparation, execution, and follow-up.
- Review quality performance metrics, KPIs, CAPA activity, defect trends, and quality improvement plans to support data-based decisions and sustainable corrective actions.
- Partner with Product Development, Engineering, and Operations to define, validate, and optimize product specifications, processes, documentation, and quality systems.
- Strengthen quality culture through accountability, training, self-inspection standards, SOP compliance, documentation discipline, and continuous improvement initiatives.

Compensation and Benefits

- Salary range: $50,000 to $80,000 per year.
- Job type: Direct hire.
- Location: Cayey, PR.

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, the Company is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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This company offers growth and a great group of people to work with.