The Wellington Group has been engaged to find a Quality Assurance Manager with expertise in overseeing QA Systems for bio-pharmaceuticals or biotherapeutics ranging from R&D, clinical trials and commercial scale production.  Exciting new opportunity to make an impact on the development of new life saving products. Who Do You Know?

This position is responsible for managing and coordinating QA efforts in multiple areas of the company. This position shall also implement strategies and procedures that are intended to comply with regulations governing pharmaceutical products as part of a quality program. The QA Manager will oversee cleanroom and sterile manufacturing compliance to include; PAIs, FDA Interactions, Lot Release, Validations, Training, Doc Control, Batch Records, CAPA, OOS, CMC Submissions Sections and other compliance needs for the company.

Position responsibilities:

• Oversees the development, implementation, and maintenance of quality assurance systems and activities including but not limited to document control, commissioning, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review/lot release
• Coordinates and ensures training on validation equipment and materials and documentation requirements in good manufacturing practices
• Coordinates and ensures that cleanrooms, their equipment, materials, layout and documentation meet good manufacturing practices
• Responsible for training employees within and outside of the department to assure up-to-date knowledge of practices and procedures of Quality Assurance
• Oversees qualification and validation plans for cleanrooms, and systems, cleaning, and process activities associated with the manufacturing of biotherapeutic and biopharmaceutical products in aseptic environments
• Assures that facilities, laboratory equipment, utility systems, and process equipment are validated and calibrated and that reports are properly written
• Creates appropriate corrective action plans to prevent or correct deficiencies
• Participates in FDA inspections, audits and other QA tasks
• Evaluates internal compliance with current standard operating procedures
• Approves validation protocols and reports
• Directs the development and implementation of validation test procedures to ensure products meet validation requirements
• Drafts initial templates and revises templates as required

The qualified candidate will have:

• Bachelor degree in life science, engineering or other related discipline
• 5 to 7 years experience with QA in an cGMP, FDA regulated manufacturing environment
• 5+ years in aseptic, sterile based environment with strong cleanroom and contamination knowledge, biopharmaceuticals and/ or biotherapeutics (injectable) is ideal
• Prior experience with the QA component of design and build of cleanrooms is ideal
• Experience with FDA site Pre-Approval Inspections (PAI) is required
• Experience in leading teams and outside vendors
• Expert knowledge in cGMP requirements
• Experienced with cleanroom pharmaceutical manufacturing
• Ability to make decisions and recommendations
• Experience with the following; document control, commissioning, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review and lot release

Industry: Quality Assurance, QA, cleanrooms, sterile pharmaceuticals, PAI, biotherapeutics, document control, commissioning, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review, lot release

Job Code: 406-32-MH2322

Location: Texas, relocation is available

Apply directly at: http://www.maxhire.net/cp/?E55E6A361D43515B7D52182B77501E6C482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( https://twgrecruiters.com) 910-338-2795

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