Quality GMP Audit Consultant

DSI encourages scientific and regulatory professionals to contact us regarding opportunities to join our dynamic team of professionals. We are currently looking to add qualified talent to the positions listed below. DSI offers a congenial work environment, the opportunity to work with knowledgeable subject matter experts in multidisciplinary teams, and flexible scheduling.

Product Life Group (PLG), a leading international pharmaceutical consulting organization, is seeking an experienced GMP Quality Auditor to conduct a broad range of GMP audits and inspection support activities for drug substance and drug product manufacturing, packaging, and testing operations on behalf of client organizations, as an hourly, independent consultant.

• Conduct GMP audits of drug substance (API) and drug product manufacturing, packaging, and testing facilities on behalf of clients,
• Perform Pre-Approval Inspection (PAI) readiness audits and mock FDA inspections to prepare client sites ahead of regulatory agency review,
• Conduct for-cause audits initiated in response to quality complaints, deviations, recalls, or prior audit and inspection findings,
• Perform inspection readiness assessments and gap analyses of quality systems, documentation practices, and facility operations,
• Conduct routine and periodic surveillance audits of qualified suppliers, contract manufacturers (CMOs/CDMOs), and contract testing laboratories,
• Support internal audits (self-inspections) on behalf of client Quality Assurance teams to identify and correct deficiencies ahead of external review,
• Perform third-party and due diligence audits of prospective manufacturing partners or acquisition targets,
• Conduct follow-up and close-out audits to verify the effectiveness of CAPAs implemented in response to prior findings or regulatory observations,
• Evaluate compliance with 21 CFR Parts 210/211, EU GMP (Eudra Lex Volume
  4), ICH Q7, and other applicable regulatory frameworks,
• Document audit findings, observations, and risk classifications in detailed, well organized written audit reports,
• Provide guidance to clients on remediation strategies, corrective and preventive actions (CAPA), and regulatory filing requirements,
• Communicate audit results clearly to client stakeholders, including quality, regulatory, and site leadership,

• B.S. in a scientific discipline (chemistry, biology, pharmacy, or related field), or an equivalent combination of education, training, and experience,
• Minimum of 10 years of experience as a GMP auditor within the pharmaceutical, biopharmaceutical, or related regulated industry,
• In depth knowledge of Drug Substance/API manufacturing and Drug Product manufacturing and packaging operations,
• Demonstrated experience conducting multiple types of GMP audits, including PAI readiness audits, for-cause audits, supplier/vendor audits, internal audits, and follow-up/close-out audits,
• Strong working knowledge of FDA, EMA, and other global regulatory agency inspection processes and expectations,
• Ability to provide written determinations confirming that active substances and drug products have been manufactured in accordance with GMP standards and associated regulatory filings,
• Competent problem solving, risk assessment, and impact analysis abilities,
• Excellent written and verbal communication skills, with strong report writing abilities,

• Prior experience as an FDA investigator, or supporting/hosting FDA or other regulatory agency inspections,
• Experience conducting mock inspections or PAI readiness assessments,
• Certified Quality Auditor (CQA), Lead Auditor certification, or similar auditing credential,
• Experience auditing sterile/aseptic manufacturing operations,
• Familiarity with data integrity requirements and computer system validation (CSV) principles,
• Capable of providing guidance on technical and regulatory requirements for the conduct of clinical trials, as well as advice on GxP issues,
• Fluency in a second language relevant to global manufacturing sites (e.g. Mandarin, German, Spanish) is a plus,
• Excellent mentoring experience,

• GMP Potential / Existing Quality Systems of Manufacturing Facilities,
• GMP Batch Record Review / QC,
• GMP Packaging, Labeling, Storage, Distribution, Destruction of Drug Product,
• GMP Risk Assessment and Mitigation - Systems, Products, Equipment,
• GMP Quality Systems Assessment, Design, Implementation,
• GMP Process and Equipment Validation Protocols and Execution,
• GMP…