Your New Company! At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences. We are better together and together We Are Altasciences. About The Role Lead the global Document Control, Archive and Training initiatives, including the development and administration of programs and employee training. Oversee the implementation and maintenance of documentation, archival systems, training and the quality management systems (QMS) used to ensure compliance with GLP, GCP, and GMP regulatory requirements across all sites. What You’ll Do Here Develop, implement and maintain the document control and training program at Altasciences, working with personnel across sites with document control, archive, training and/or QMS responsibilities. Directly oversee the document control staff that maintain, edit, review and administer the controlled documents maintained in QMS. Directly oversee archive staff that perform the submission, maintenance, retrieval and disposition of archive records and specimens. Directly oversee training staff that maintain the training programs in the QMS/LMS. Directly oversee the staff involved with maintenance and use of the QMS system, including for document control and training. Maintain computerized files to support all document control, archive and training functions. Represent management regarding document control, archive, training and QMS activity needs. Develop and oversee the maintenance of training record matrices and files for all employees. Prepare and update SOPs for document control and archive activities. Participate as company representative on Sponsor visits and regulatory inspections. Perform training of staff by conducting training seminars and distributing information on GXP regulatory requirements for document control, archive and training processes. Advise management on strategic plans to ensure that the document control, archives. training documentation and QMS management processes meet regulatory requirements and are optimized. Identify and implement process improvement ideas/changes and develop and maintain metrics for document control, archives, training records and QMS use. Oversee the maintenance of training within the QMS/LMS system, including consulting with every site/functional area on their training program and programing within the system. Help facilitate upgrades in QMS system with IT and validation staff and assist with rollout of QMS system to all company sites through planning, training and implementation. Responsible for safeguarding the integrity, security, and accessibility of controlled documents and archived records, ensuring they are properly maintained and readily accessible across preclinical, clinical, and manufacturing environments. Assist all sites and functional areas with document control, archive and training documentation functions and collaborate with sites to harmonize processes. Assist with cross-departmental projects to help meet company goals and objectives. What You’ll Need to Succeed Bachelor’s degree or equivalent. Five (5) or more years of experience in document management, archives, training, quality management system management and/or a regulatory environment. Ability to multi-task and maintain organization in a fast paced, changing environment. Demonstrate administrative capabilities. Demonstrate knowledge working in a regulatory environment. A minimum of 3-5 years previous supervisory experience. Proficiency in Microsoft Office products. Proficiency with MasterControl software. Knowledge of LMS systems. For Canada: Fluency in both French and English languages for written and verbal communication. For United States: Fluency in English language for written and verbal communication. Ability to read, write and interpret instructions and procedures; ability to write routine reports and correspondence; ability to speak effectively before groups. Ability to understand and perform basic math. Continual GxP & regulatory training, computer software applications and document control processes. Ability to operate independently with minimal guidelines. Comfortable with communicating with all levels of management and employees. Ability to identify and resolve issues as they are encountered. Fosters a cooperative and harmonious working climate conductive to maximize employee morale and productivity. Strong planning and organizational skills. Proven presentation and facilitation skills. What We Offer: Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work. Altasciences' Benefits Package Includes: Health/Dental/Vision Insurance Plans 401(k)/RRSP with Employer Match Paid Vacation and Holidays Paid Sick and Bereavement Leave Employee Assistance & Telehealth Programs Altasciences' Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program Annual Performance Review #LI-MB1 MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
