Global Quality & Compliance Lead

PCI SCP Sherpa Clinical Packaging; San Diego (CA); On-site; USD 76,000 - 86,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services is seeking a Quality Compliance professional to ensure regulatory compliance with FDA, DEA and international requirements. You will coordinate audits, manage CAPAs, and oversee quality documentation across the site.

Responsibilities include maintaining customer quality agreements, site master files, and continuous improvement practices while supervising Quality Compliance staff and aligning with PCI policies and cGMP/GCP standards.

Qualifications

• Bachelor's Degree in a related field and/or 3-5 years related experience and/or training.
• College Level Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
• High Standard of Report Writing Preferred:
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display original thinking and creativity.
• Ability to adapt to changing work environments.

Responsibilities

• Ensure compliance with FDA/DEA and other regulatory requirements.
• Coordinate and oversee audit program and responses.
• Maintain communication of audit findings and CAPAs.
• Review Customer Quality Agreements.
• Review and maintain Site Master Files and related documents.
• Support programs promoting quality and regulatory compliance.
• Use continuous improvement tools to strengthen compliance.
• Perform or coordinate supplier audits with potential cGMP impact.
• Support inspection readiness activities.
• Monitor audit observations and ensure timely closure of actions.
• Provide supervision to Quality Compliance personnel.
• Maintain knowledge of PCI policies, cGMP, and GCP.

Skills

Bachelor's degree

Math skills

Advanced computer skills

English proficiency

Analytical thinking

Problem solving

Communication

Adaptability

Education

Bachelor's degree

Job description

PCI Pharma Services is seeking a Quality Compliance professional to ensure regulatory compliance with FDA, DEA and international requirements. You will coordinate audits, manage CAPAs, and oversee quality documentation across the site.

Responsibilities include maintaining customer quality agreements, site master files, and continuous improvement practices while supervising Quality Compliance staff and aligning with PCI policies and cGMP/GCP standards.