QA Contractor Specialist IV - Audits and Supplier Quality

Job Description

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.

Equal Opportunity

Employer:

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate.

We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate…