Job Description

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The Company

BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

Why Us?

• It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact!
• Everything we do - and we do it with passion - is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
• We're growing, and so will you with leaders who will support your development through mentorship and other opportunities

• Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

The Role

The Manager oversees the activities of the Quality Control staff members during the conduct of the studies at BioPharma Services Inc. Lead and coach Quality Control staff members to ensure all study related activities are performed in compliance with Protocol, BPSI SOPs and regulations, while providing guidance and directions to Quality Control staff members. Responsible that all study related documentation is reviewed to ensure the quality, reliability, accuracy, completeness, and consistency according to Protocol, SOPs, GCP guidelines and applicable regulatory requirements, as well as adherence to the assigned timelines.

You Will Have The Opportunity To:

• Provides leadership maintaining, directing, and enhancing the clinical Quality Control department.
• Collaborates with other clinic departments such as Pharmacy, Clinical Operations,
• CRCs, QA, Data Management, Medical Writing to ensure the study documents
• and electronic data reviewed, and studies are conducted with high-standard
• quality.
• Applies sound judgment in making quality related decisions and problem solving
• Oversees planning and hiring activities, performance evaluations and routine monitoring of productivity. Facilitates knowledge development; oversees, organizes, and conducts QC training as appropriate
• Employee performance management including monitoring, performance reviews, recommendations, and discipline, as necessary
• Communication and implementation of Quality objectives, requirements, and initiatives
• Supervises and schedules Quality Control (QC) staff, as well as the QC activities to be performed during the conduct of studies
• Ensures efficiency and mobilization of the QC staff to achieve expected results
• Establishes and maintains quality standards for QC and ensures adherence to study protocols, BPSI SOPs, Directives, and ICH-GCPs guidelines and regulatory requirements
• Assists QC staff in addressing study related issues
• Analyzes and develops action plans to address QC findings, including development of CAPA reports
• Maintains current professional knowledge base of quality control methodologies and regulatory requirements (FDA, TPD, etc.)
• Maintains adequate, accurate, complete, and legible records
• Ensure all study related activities are performed in compliance with Protocol, BPSI SOPs and regulations
• Ensure all prepared study source documents and/or forms are in accordance with protocols, SOPs, and regulations
• Ensure the study files after completion are accurate and legible according to protocol, SOPs, and regulations
• Review all other study related documentation: medical screening files, pharmacy labels and files
• Ensure the conduct of clinical trial according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BPSI SOPs at all times
• Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
• Observe, on the random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
• Provide reports of the reviewed data to relevant personnel/department
• Develop and utilize QC Checklist or other QC tools designed to document the QC review process
• Perform training of new QC Staff
• Provides input to the clinic calendar, assists Senior Management with daily operations as required
• Participate in review of SOPs and Protocols
• Involve/Assist in Clinical Software data integrity, data/procedure validation and compliance to 21CFR part 11 and GxP standards
• Performs other tasks and projects as assigned

What You Will Bring:

• Completed Post-secondary degree in a science or healthcare related discipline, or
• equivalent work experience.
• 4+ years of relevant clinical research experience, knowledge of ICH-GCPs and
• professional experience working in CRO
• Ability to accommodate a flexible work schedule and to adapt to changing
• priorities; able to work under pressure.
• Excellent attention to detail
• Excellent communication skills
• Excellent computer skills
• Excellent Leadership skills
• Certification in Clinical Research is an asset.

Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment.

We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs.