Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Summary: Lead the activities of the Document Control & Training team to support compliance of our site to documentation and training requirements. Perform as Site System Owner for the Electronic Document Management System (eDMS) and Learning Management System (LMS) to ensure they meet validated and regulatory requirements at the site. Responsible for GMP document workflows through the respective document lifecycles at Whitby Region Operations (WRO). Ownership of the Corporate Quality Standards alignment process at the site. Perform Good Manufacturing Practices (GMP) Training to employees as part of the new onboarding program. Lead specifications for finished products (FP), intermediates and raw materials, and issuance of Certificates of Analysis. Support client and regulatory audits. Essential Functions: Supervise the Document Control & Training team to create a culture of quality awareness, teamwork, compliance, and continuous improvement. Mentor and train the Document Control & Training team to provide the best cross functional service through effective communication, leadership, and problem solving. Perform as Site System Owner for eDMS and LMS Maintain eDMS and LMS in compliance with all applicable regulations, corporate requirements, and site procedures. Ownership of eDMS and LMS related Standard Operating Procedures (SOPs), Work Instructions (Wis) and associated training materials. Responsible for document lifecycle workflows through eDMS and LMS: review, approval, effective date assignment, assignment of training, inactivation as required, course creation, training verification, curricula maintenance, and curricula removal as required. Collaborate cross functionally to support various documentation and training needs to ensure compliance to requirements. Deliver training as required in support of eDMS and LMS function. Troubleshoot eDMS and LMS issues and provide support to end users Manage performance by identification, monitoring, trending, and reporting of metrics. Oversee the periodic (triennial) review process of SOPs, WIs, and LMS training curricula. Ensure site document alignment to Corporate Quality Standards and Guidelines. Manage the archive, retention, and destruction process for GMP documentation in accordance with requirements. Lead the creation and revision of specifications for finished products, intermediates, and raw materials. Oversee the issuance of Certificates of Analysis for In-Process, Raw Material, Bulk and Finished Product. Support vendor change assessments, material gap analysis, and compendial update assessments. Initiate Change Controls for Analytical Release Forms, Control Procedures, and Certificates of Analysis. Attend Client meetings and internal readiness meetings as required. Support regulatory and client audits as site SME for processes and procedures in scope of role. Promote a safe working environment, report potential hazards, and ensure all direct reports follow Environmental Health and Safety procedures. REQUIRED QUALIFICATIONS Education: Bachelor of Science (BSc) in Chemistry, Biology, Pharmacy, Engineering, or related field. Experience: Minimum 8 years’ experience within the pharmaceutical industry. Minimum 5 years’ experience in Quality or Compliance within the pharmaceutical industry. Minimum 3 years supervisory and/or leadership experience. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills, and Abilities: Demonstrated computer proficiency with Microsoft Office programs. Intermediate Excel proficiency and previous database experience. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent organizational skills and ability to prioritize in a face-pace environment. Works well and efficiently with limited supervision. Strong written and oral communication skills. Proficiency with the 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 SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order 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. Disclaimer: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
