Associate Director – GMP Operational Quality Assurance Medical Device

Associate Director – GMP Operational Quality Assurance Medical Device

Requirements

• Seven (7) + years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in cGMP related industry, with four (4) or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities.
• Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.)
• Knowledge of standard microbiological procedures (sterility testing, environmental monitoring, bioburden, and bacterial endotoxin testing)
• Must have experience in ethylene oxide, steam sterilization, and gamma radiation requirements.
• Knowledge of FDA cGMP, ISO 14644-1 standards, ISO 11135, and other sterilization related documents
• Demonstrated experience providing QA support and oversight of GMP manufacturing operation.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Oracle, Veeva
• Understanding of regulatory environment including quality systems and compliance.
• Must have strong technical writing skills.
• Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams.

Responsibilities

• Provides quality assurance support in design and development activities of combination medical device products and facilitates the application of design controls and risk management. Supports Design History File establishment, creation, approval, and maintenance.
• Reviews and approves design documentation including, but not limited to verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents (design and process).
• Develop, implement, and maintain quality management systems for sterilization processes and microbiological testing in accordance with regulatory requirements (e.g., FDA and ISO).
• Collaborate and provide guidance and support in areas such as sterilization validation, microbiological testing methodologies, and data analysis.
• Oversee microbiological testing procedures both internally and externally at Contract Testing Laboratories.
• Conduct risk-assessments and implement corrective and preventive actions (CAPAs) to address any deviation or nonconformities identified during sterilization or microbiological testing processes.
• Stay abreast of industry trends, regulatory updates, and emerging technologies related to sterilization and microbiology, and incorporate relevant changes into quality management systems.
• Serve as a subject matter expert on sterilization and microbiology testing matters, providing guidance and support to internal stakeholders and external partners, as needed.
• Provides leadership in all areas of the Quality System, including, but not limited to Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions (internal and external).
• Perform appropriate duties as assigned by management.

Preferred Qualifications

• Preferred Master’s degree or relevant comparable background.
• Knowledge of ISO 13485, ISO 14971 and combination product standards is an advantage.