Senior Manager, Quality Assurance
Remote, Canada
Quality Assurance – Quality Assurance /
Full Time - Regular /
Remote
What We Do
Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview
The Senior Manager, Quality Assurance oversees the activities of the Quality Assurance function and reporting staff. This role is responsible for ensuring that our clinical research activities conform to regulatory requirements, industry best practice, company policies and procedures, with and in support of the Quality Assurance Management team, to ensure that Care Access maintains a high level of quality.
What You'll Be Working On
Duties include but not limited to:
Primary Duties and Essential Functions-
-Oversee the daily workflow and schedules of the department. Provide coaching and supervision to QA team, training and onboarding new staff, and ensuring team members are performing to standard of their role. Serve as the GCP lead by providing high standard of quality guidance, advice and support on GCP compliance. Manage and maintain databases for the quality systems and provide quarterly reports and quality metrics to Head of Quality Assurance. Prepare reports to track and communicate outcomes of quality assurance activities.
-Creation and tracking of the internal audit program for clinical research sites, departments, processes and vendors. Oversee and participate in its execution, peer review staff audit reports, ensuring effectiveness and compliance with regulatory requirements, company policies, and procedures. Manage, co/host and participate in preparation and execution of client audits and regulatory authority inspections.
-Collaborate with other departments and stakeholders to ensure that quality issues are addressed in a timely and effective manner. Coach and train operational staff on quality processes, including but not limited to reporting of quality issues, root cause analysis, CAPA development.
-Develop and implement policies and procedures for quality assurance activities. Review, and revision of quality assurance SOPs and procedures.
Other Responsibilities-
-Keep up-to-date with the latest regulatory requirements and industry best practice related to clinical research.
Scope of Role
· Autonomy of Role: Team member has complete autonomy over work performed
· Direct Reports: Yes
· Number of Direct Reports (if applicable): 5-7
· Role(s) Managing: QA Specialist, QA Lead, Senior Auditor, QA
Physical Requirements
· This role requires 100% of work to be performed in a remote or other office environment and requires the ability to use keyboards and other computer equipment.
Travel Requirements
· This role requires up to 25% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
o Type of travel required: International
What You Bring
Knowledge, Skills, and Abilities:
· Excellent working knowledge of medical and research terminology
· Excellent working knowledge of applicable regulations and good clinical practices (GCP)
· Attention to detail
· Ability to communicate and work effectively with a diverse team of professionals
· Strong Organizational Skills: Able to prioritize, delegate, direct, support and evaluate others work and follow through on assignments
· Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.
· Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals
· Strong computer skills with demonstrated abilities using clinical trials databases, IXRS systems, delectronic data capture, MS word and excel
· Ability to balance tasks with competing priorities
· Demonstrate effective decision making skills
· Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
· High level of self-motivation and energy
· Ability to work independently in a fast-paced environment with minimal supervision
· A customer/client centric service mentality
Certifications, Education, and Experience:
· Bachelor’s Degree or equivalent research experience
· A minimum of 8 yrs experience in clinical research, with a minimum of 5 yrs of experience in quality assurance within a site management, CRO or Pharma organization or equivalent environment
· Experience of performing different type of quality audits e.g., investigator site audits, vendor audits, process audits
· Experience of regulatory inspections e.g. FDA, EMA
· Experience of sponsor/CRO audit process
· Direct line management experience will be an asset
Licenses:
· Not applicable
Diversity & Inclusion
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
