https://CAREERS.PLANET-PHARMA.COM/ en-us Position Title: QA Contractor (Specialist IV, Audits and Supplier Quality)     
Location: (Onsite) Houston, TX
Department: Quality Assurance


Responsibilities

• Plan, schedule, lead, and execute internal and external (supplier/vendor) quality system audits according to established procedures and regulatory requirements.
• Maintain and improve audit program, including audit schedules, checklists, and reporting.
• Ensure audit readiness for regulatory inspections and host regulatory inspections as required.
• Develop risk-based audit plans and establish audit schedules in alignment with business priorities.
• Review, approve, and track non-conformances, observations, and Corrective and Preventive Actions (CAPA) resulting from audits to ensure timely and effective closure.
• Prepare comprehensive audit reports detailing findings, observations, and compliance status. Present audit results and key quality metrics to senior management.
• Lead the initial qualification and ongoing re-qualification of critical suppliers, including system assessments, on-site audits, and technical reviews to ensure robust Quality Management Systems (QMS).
• Plan, execute, and report on supplier and contractor audits globally, including CMOs, CROs, raw material providers, and service suppliers.
• Draft, negotiate, review, and ensure the execution and maintenance of comprehensive Supplier Quality Agreements (SQAs) with key suppliers, outlining mutual quality responsibilities to ensure alignment with regulatory expectations and company standards.
• Develop, monitor, and analyze key Supplier Quality Performance Indicators (KPIs) and metrics (e.g., defect rates, on-time delivery, CAPA effectiveness). Drive performance reviews with underperforming suppliers.
• Act as a final escalation point and lead cross-functional teams (including Procurement, Engineering, and Manufacturing) in complex root cause analysis (RCA) and implementation of Corrective and Preventive Actions (SCARs/CAPAs) for supplier-related quality issues to evaluate and mitigate supplier risks.
• Review and approve supplier-initiated change notifications, assessing their potential impact on product quality and compliance, and ensuring necessary internal actions are taken.
• Identify, develop, and implement strategies for continuous improvement within the SQM and Audit processes to enhance efficiency, reduce risk, and improve overall product quality.
• Conduct and maintain supplier risk assessments (e.g., criticality, quality history) to focus resources on the highest-risk areas of the supply chain.
• Triage supplier change notifications, assess material/specification changes, and initiate or coordinate change controls as required. 
• Mentor and train junior quality specialists and cross-functional partners on audit techniques, supplier quality requirements, and use of quality tools (e.g., RCA, FMEA).
• Author, review, and approve departmental Standard Operating Procedures (SOPs) and work instructions related to supplier quality and auditing.
• Other duties as assigned.

Qualifications/Skills

• Bachelor’s degree in Life Sciences, Engineering, or related discipline required; advanced degree preferred.
• 8+ years of progressive experience in Quality Assurance, supplier quality management, or GMP auditing within the pharmaceutical, biotechnology, or medical device industry.
• Understanding of Cell and Gene Therapies. 
• Certified Quality Auditor (CQA), ISO Lead Auditor, or equivalent certification strongly preferred.
• Demonstrated experience hosting and supporting FDA, EMA, MHRA, or other regulatory inspections.
• Experience with Health Authority regulations (US FDA, EMA, ISO 9001, ISO 13485, etc.) preferred.
• Understanding of GxPs.
• Advanced understanding of supplier qualification, auditing principles, and risk management tools.
• Knowledge of local and global regulations. 
• Excellent verbal and written communication skills. 
• Excellent interpersonal and customer service skills. 
• Excellent organizational skills and attention to detail. 
• Excellent time management skills with a proven ability to meet deadlines. 
• Strong analytical and problem-solving skills. 
• Proficient with Microsoft Office Suite or related software. 

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