Manager, Clinical Quality Control Department

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  are better together and together We Are Altasciences.

• Management of the Quality Systems team, including but not limited to, PTO management, timesheet approval, on-going and yearly performance reviews, employee hiring, disciplinary actions and termination.
• Perform, direct and/or oversee the training of the Quality Systems team.
• Proactively assess learning opportunities for the Quality Systems team.
• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Maintain and advocate a high level of quality and customer service within the department.
• Participate in sponsor/regulatory audits, respond to and/or complete pre-site audit questionnaires and audit reports.
• Review quality inputs/deviations, track trends and evaluate the QC process and risk mitigation; expedite as required.
• Implement quality initiatives and process improvements within the department.
• Monitor clinical trial timelines to ensure clinical trial data milestones are met related to data entry, query tracking and resolution, and deviation management.
• Participate in SOP revisions.
• Perform and/or ensure the training on external databases.
• Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
• Hold meetings to communicate clinical trial needs and/or departmental objectives.

• Management of the Quality Systems team, including but not limited to, PTO management, timesheet approval, on-going and yearly performance reviews, employee hiring, disciplinary actions and termination.
• Perform, direct and/or oversee the training of the Quality Systems team.
• Proactively assess learning opportunities for the Quality Systems team.
• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Maintain and advocate a high level of quality and customer service within the department.
• Participate in sponsor/regulatory audits, respond to and/or complete pre-site audit questionnaires and audit reports.
• Review quality inputs/deviations, track trends and evaluate the QC process and risk mitigation; escalated as required.
• Implement quality initiatives and process improvements within the department.
• Monitor clinical trial timelines to ensure clinical trial data milestones are met related to data entry, query tracking and resolution, and deviation management.
• Participate in SOP revisions.
• Perform and/or ensure the training on external databases.
• Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
• Hold meetings to communicate clinical trial needs and/or departmental objectives.

• College or University Degree completed.
• Minimum of 3 years of experience in the clinical research field.
• 3 to 5 plus years related experience in management of a team.
• Microsoft suite.
• Strong computer literacy.
• Ability to read and interpret technical documents and industry specific manuals. Ability to write advanced reports and correspondence.
• Bilingual proficiency in English/French.
• Excellent verbal and written communication skills.
• Well-developed interpersonal skills are required.
• Personal/professional integrity and proven discretion in handling confidential information.
• Ability to develop strong trusting relationships in order to gain support and achieve results.
• Must be self-directed, motivated, and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for…