Job Description

　　Summary:

　　Lead the design, implementation, and integration of Digital Solutions within the Quality organization. Acts as a liaison between stakeholders at the site, and corporate IT & Quality teams. Primary responsibility is strongly focused on AO/DO Lab operations.

　　Essential Functions:

　　Project Management:

　　Manage deployment of approved digital projects with assistance from Management. Serve as TRO site D2/edms subject matter expert, a touchpoint between TRO and central eDMS team. Assist with the design and implementation of D2/eDMS digital solutions within the site, related to replacement of paper-based systems and documentation with digital workflows (ex: GMP forms) Project manage the deployment of Sample Manager at the TRO site within the AO/DO labs. Project manage the deployment of Smart QC at the TRO site within the AO/DO labs. Design & execute appropriate pilot scale laboratory execution system (LES) projects, assess results, recommend next steps based on total cost of ownership and return on investment. Resolve project issues and resource constraints within the team and with moderate assistance. Facilitate positive team member interactions and manages conflict with minimal assistance. Establish / Practice standard project reporting procedures to client and management (i.e. minutes, agendas). Maintain & update long term lab digital transformation plan, with project sequencing and dates. Ensure adherence to 21 CFR Pt 11 regulations for deployed solutions where appropriate.

　　Author change controls and project documents as appropriate, to ensure compliant deployment plan. Participate in continuous improvement initiatives to drive the performance of the Quality Department, the site and the Network (as appropriate)

　　Client Management:

　　Manage client satisfaction by managing client expectations efficiently with minimal assistance from Management.

　　Business Management:

　　Plan, monitor and ensure completion of all activities outlined in the project plan for each project. Create and maintain project timelines. Assess and report total cost of ownership performance for legacy and updated processes.

　　People Management:

　　Co-ordinate the efforts of the team assigned to the project. Facilitate positive team member interactions and manages conflict with minimal assistance. Support onboarding and training for new hires within the Quality Department as it relates to the project.

　　REQUIRED QUALIFICATIONS

　　Education:

　　Bachelor's degree in Science, Engineering or Business an asset.

　　Experience:

　　Minimum 4 years industry experience in a GMP environment.

　　Project Management Professional (PMP) certification is an asset

　　Equivalency:

　　Equivalent combinations of education, training, and relevant work experience may be considered.

　　Knowledge, Skills and Abilities:

　　Well organized with strong attention to detail. Ability to prioritize multiple project deliverables in a fast-paced work environment. Ability to meet deadlines and prioritize. Excellent written and oral communication skills. Ability to handle conflict effectively. Strong customer focus and commitment to results. Familiarity with Good Manufacturing Practices and lab operations. Ability to work both in a team environment as well as independently. Demonstrated computer proficiency with Microsoft Office programs and database management skills. Proficiency with English language.

　　Standards and Expectations:

　　Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

　　Physical Requirements:

　　Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.