PCI Pharma Services

PCI Pharma Services

Senior Compliance Specialist

San Diego, CA, USA · Senior · Full-time

Sponsorship not specified$85k-$96kDetected 28 days ago
GCPComplianceAuditingLogisticsGMPFDA RegulatoryCommunicationTime ManagementInternal Audit

About the role

  • Bridge to thousands of biopharma companies and their patients.
  • Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.
  • Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.

Responsibilities

  • Support the execution of the internal and external audit program, including audit preparation, scheduling coordination, and documentation.
  • Lead and support customer audits and regulatory inspections, including audit preparation, logistics coordination, SME readiness, front- and back-room facilitation, audit hosting, and support of inspection responses (e.g., FDA 483 responses).
  • Support the development, tracking, communication, and closure of audit responses, audit observations, and regulatory inspection findings, including associated CAPAs and their effectiveness verification.
  • Lead or support site inspection readiness activities, including participation in mock inspections, gap assessments and training initiatives.
  • Lead or support internal audits (self-inspections) to assess compliance with cGMP, GCP (as applicable), and company procedures.
  • Support the review and maintenance of Customer Quality Agreements, ensuring alignment with compliance expectations.
  • Support the preparation, review, and maintenance of Site Master Files and other regulatory documentation to ensure accuracy and inspection readiness.
  • Utilize continuous improvement tools and methodologies to support trend analysis, root cause investigations, and compliance improvements.
  • Support trending of audit findings, deviations, and CAPAs to identify potential compliance risks and support Quality Management Review (QMR).
  • Support and contribute to the effectiveness of the Quality Management System (QMS), including investigations, change controls, deviations, CAPAs, and document control.

Requirements

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
  • Strong knowledge of cGMP regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q9, Q10).
  • Experience with risk-based audit programs and inspection readiness activities.
  • Bachelor's Degree in a related field and/or 3-5 years related experience in a regulated industry.
  • Minimum of three (3) years of relevant QA experience in a GMP-regulated environment.
  • Experience supporting internal audits, customer audits, or regulatory inspections
  • Working knowledge of cGMP regulations (21 CFR Parts 210/211) and applicable ICH guidelines (Q7, Q9, Q10)
  • Familiarity with Quality Management Systems (e.g., Master Control, Track Wise, Veeva)
  • Understanding of Data Integrity principles (ALCOA+) including knowledge of 21 CFR Part 11.
  • Knowledge and hands on experience with QMS data management software such as Master Control, Track Wise, Veeva, etc.
  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Required:
  • Basic Mathematical Skills
  • Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

Skills

  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • High Standard of Reporting Writing
  • Experience in a CDMO or pharmaceutical manufacturing environment
  • Experience supporting risk-based audit programs and inspection readiness activities
  • Experience working directly with clients and cross-functional teams
  • Strong written and verbal communications skills
  • The hiring rate for this position is $85,120-$95,760 plus eligibility for an annual performance bonus.
  • Let's talk future
  • Equal Employment Opportunity (EEO) Statement:
  • PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
  • At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies.

Compensation

  • The hiring rate for this position is $85,120-$95,760 plus eligibility for an annual performance bonus.

Company info

  • Together, delivering life-changing therapies.
  • We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
  • We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Equal opportunity

  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Visa & Work Authorization

  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.