Director Aseptic Compliance, Training Material & Batch Release

Glenmark Pharmaceuticals•Monroe, NC

2d•Onsite

About The Position

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.

Requirements

Broad educational background and experience in microbiological principles.
Ability to communicate requirements to trainees.
Working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.
Compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed.
Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.

Nice To Haves

Experience in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBE's).
Experience in a fast growing and robust US generics business.
Experience in moving into the innovative market.
Experience marketing APIs to regulated and semi-regulated countries.
Experience in a company with over 10,000 employees in more than 60 countries.
Experience in a company with twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.
Experience in a phase of immense growth both in the U.S. and abroad.
Experience in a leading integrated research-based pharmaceutical company.
Experience in leading the development of training and certification/qualification programs.
Experience in delivery of training sessions.
Experience in maintenance of ongoing metrics associated with aseptic manufacturing practices at the site.
Experience in ensuring activities are appropriately tracked in the Learning Management System (LMS).
Experience providing technical proficiency and consultative guidance as an aseptic subject matter expert (SME).
Experience collaborating with all levels of Aseptic Manufacturing to confirm aseptic training plan objectives are met through effective learning and training solutions.
Experience serving as the site’s POC (Point of Contact) for providing advice concerning enhancements to aseptic practices, certification program and other training related projects.
Experience overseeing disposition of Raw materials and Finished Products from the Site following applicable site procedures including but not limited to batch record review.
Experience in preparation of Revenue and Capex Budget.
Experience in ensuring financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
Experience in maintaining quality system controls to ensure no critical and major market complaints.
Experience in taking appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
Experience in developing the various positions and roles and responsibilities necessary for the Aseptic Compliance and Training Department.
Experience in leading 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.
Experience in leading 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.
Experience in leading the activities required to develop and deliver GMP training modules related to proper aseptic behavior and maintaining an aseptic environment.
Experience in leading 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.
Experience in coaching and mentoring employees on the importance of maintaining low bio burden during line clearing/cleaning, runs, routine and non- routing interventions.
Experience in assessing work environment to ensure it is suitable to enable good aseptic behaviors and makes recommendation to management on changes needed.
Experience in partnering 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.
Experience in leading 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.
Experience in 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.
Experience in participating in cross-functional risk assessments and process parameter classification.
Experience in participating in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.
Experience in participating on interdepartmental project / program teams to meet company / site milestones and objectives.
Experience in management of Batch Release, Raw material and Packaging Material releases.
Experience in support of and coordination with all cross functional teams for documentation needs within the site for materials and batch release.
Experience in providing technical assistance in upgrades and improvement of facility design to meet current industry practices.
Experience in staying abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met.
Experience in actively seeking out new, cutting edge technology to further Quality Operations initiatives and build efficiencies.

Responsibilities

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.
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.
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
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