Associate Director, GMP Operational Quality Assurance Medical Device (On site)

Job description

Job Description

General Summary

The GMP Operational Associate Director is recognized as an expert internally in the principles and application of quality assurance and compliance.

The GMP Operational Associate Director will provide QA support of manufacturing operations, oversee sterilization processes and microbiological testing, and serve as a Product Quality Lead for the activities supporting Cell & Genetic Therapies.

The GMP Operational Associate Director should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility.

This individual should be willing to make a significant contribution to a multi-disciplinary team, must be self-motivated to take action, and have excellent written and verbal communication skills.

The qualified candidate will act provide quality assurance support quality systems and compliance activities working cross-functionally with R&D, Product/Process Development, Manufacturing, Supply Chain, QC and QA.

This individual will have a strong background, experience and/or understanding in Design Controls, Risk Management, Quality Systems, GMP Manufacturing and Combination Medical Devices.

***This is an On-site role in Providence, Rhode Island)***

Key Duties and 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.

Required Education Level and Experience:

• 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.
• Preferred Master's degree or relevant comparable background.

Required Experience, Knowledge/Skills

• 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)

• 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
• Able to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
• Able to integrate activities with other groups, departments and project teams as needed.
• 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.
• Knowledge of ISO 13485, ISO 14971 and combination product standards is an advantage.
• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience, judgement, and a risk-based approach.
• Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry.
• Ability to evaluate quality matters and make decisions utilizing risk-based approach.
• 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.

On-Site Roles

·         In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Required Skill Profession

Operations Specialties Managers