Manager, Clinical Quality Control Department

Altasciences; Montreal (administrative region); Hybrid; CAD 85,000 - 110,000; Full time

Benefits offered by this job

Health/dental/vision insurance plans

RRSP with employer match

Paid vacation and statutory vacations

Paid sick leave and bereavement leave

Employee assistance and telehealth

Job summary

Altasciences is searching for a Clinical Quality Control Associate to lead the Quality Systems team in Montreal. The role encompasses training, audits, and risk management to ensure high standards across clinical trials.

You will supervise personnel, maintain confidentiality, and drive continuous improvement while coordinating with sponsors and regulatory bodies in a bilingual environment.

Qualifications

• College or University Degree completed.
• Minimum of 3 years in clinical research field.
• 3–5+ years in management of a team.
• Proficient with Microsoft Office; strong English/French communication.

Responsibilities

• Manage the Quality Systems team and related personnel processes.
• Oversee training of the Quality Systems team.
• Ensure confidentiality of trial participants and sponsors.
• Participate in sponsor/regulatory audits and audit reports.
• Review deviations, track trends, and mitigate risks.
• Lead quality initiatives and process improvements.

Skills

Quality Systems Management

Leadership

Training & Development

Communication

Bilingual English/French

Education

College or University Degree completed.

Tools

Microsoft Office Suite

Job description

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

• 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.

What You’ll Do Here

• 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.

What You’ll Need To Succeed

• 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 implementation.
• Customer service focused.
• Able to work in fast-paced environment with conflicting priorities.

Altasciences Strives To Provide a French Working Environment For Its Employees In Quebec. Although As Part Of Its Francization Program Has Taken All Reasonable Steps To Avoid Imposing The Above-mentioned Requirement. Fluency In English Is An Essential Requirement For The Position Of Clinical Quality Control Associate Including, But Not Limited To, For The Following Reasons

• The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

What We Offer

• Regular full-time position; 37.5 hours a week.
• Candidate needs to be available between 7am and 5pm.
• Hybrid position (3 days on site, Montreal site (1200 Beaumont) - 2 days remote).
• Needs to be available to be full time on site for the training period.
• Accessible by metro (L'Acadie); Free parking for employees.

Altasciences offers a wide range of benefits to help employees live healthy and satisfying lives, both on and off the job.

Altasciences Benefits Include

• Health/dental/vision insurance plans
• RRSP with employer match
• Paid vacation and statutory vacations
• Paid sick leave and bereavement leave
• Employee assistance and telehealth programs

Altasciences' incentive programs include

• Training and development programs
• Employee orientation bonus program
• Annual performance reviews

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!