Director

POSITION SUMMARY

The Director of Aseptic Compliance and Training is responsible for leading the development of training and certification/qualification programs, delivery of training sessions, and maintenance of ongoing metrics associated with aseptic manufacturing practices at the site. The position is also responsible for ensuring that activities are appropriately tracked in the Learning Management System (LMS). The Director of Aseptic Compliance and Training role will provide technical proficiency and consultative guidance as an aseptic subject matter expert (SME), and must also have the ability to communicate these requirements to trainees who have a broad educational background and experience in microbiological principles. The Director of Aseptic Compliance and Training collaborates with all levels of Aseptic Manufacturing to confirm aseptic training plan objectives are met through effective learning and training solutions. They serve as the site's POC (Point of Contact) for providing advice concerning enhancements to aseptic practices, certification program and other training related projects. This role also oversees disposition of Raw materials and Finished Products from the Site following applicable site procedures including but not limited to batch record review. Raw material includes API, Excipients, Packaging Materials and Consumables.

OVERALL JOB RESPONSIBILITIES

Responsibilities

Results Expected/ Target

Financial

• Preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site
• Maintain quality system controls to ensure no critical and major market complaints
• Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.

Operational Excellence

• Develop the various positions and roles and responsibilities necessary for the Aseptic Compliance and Training Department.
• Lead the development and implementation of policies and procedure as required to support the day to day activities of the department including periodic evaluation by shop floor oversight.
• Lead the development and administration of the aseptic behavior certification program for employees working in the manufacturing aseptic environment including operational staff, cleaning staff, microbiology, maintenance staff, etc.
• Lead the activities required to develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment.
• Lead efforts to drive continuous process improvement activities with the dual goals of reducing risks of contamination, reducing waste, increasing process efficiency, and reducing safety hazards.
• Coach and mentor employees on the importance of maintaining low bio burden during line clearing/cleaning, runs, routine and non- routing interventions.
• Maintain working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing. Assess work environment to ensure it is suitable to enable good aseptic behaviors and makes recommendation to management on changes needed.
• Partner with Operational and Environmental Control staff in supporting the investigation of events linked to microbial contamination and in particular, defining CAPA's associated with human aseptic practices.
• Lead the training program for the site from QA perspective including but not limited to curriculum, timely completion of assigned training, providing feedback to QADC for implementation of documents based on training completion etc.
• Responsible for tracking and trending matrix associated with batch record errors and right first time concept at site and providing leadership on reducing errors and timely disposition of materials and products manufactured.

Stakeholder

• Ensure compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed.
• Participate in cross-functional risk assessments and process parameter classification
• Participates in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.
• Participate on interdepartmental project / program teams to meet company / site milestones and objectives
• Responsible for management of Batch Release, Raw material and Packaging Material releases.
• Responsible for support of and coordination with all cross functional teams for documentation needs within the site for materials and batch release

Innovation

• Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements. Providing technical assistance in upgrades and improvement of facility design to meet current industry practices.
• Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met. Actively seek out new, cutting edge technology to further Quality Operations initiatives and build efficiencies

KNOWLEDGE, SKILLS AND ABILITIES:

Education

• Requires Bachelor's Degree and/or equivalent relevant experience in a scientific field, or aseptic manufacturing.

Experience

• 8+ years of management experience in an aseptic manufacturing environment
• Experience in an aseptic environment or supporting aseptic manufacturing preferred.
• Training experience is essential

Knowledge and Skills (Functional / Technical)

• Knowledge of current cGMP regulations.
• Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Strong organizational skills.
• Time management
• Requires thorough/working knowledge of GMP's, PICS and ISO and expertise in sterile processing. Must have demonstrated ability to handle multiple projects in a dynamic environment.
• Must be able to take complex principles and concepts and break them down into teachable elements so colleagues can quickly understand.

Leadership / Managerial Attributes

• 3-5 direct or indirect reports