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Quality Assurance Manager

MoltenFray Systems
Calgary, Alberta, T3N 1A6, Canada
June 14, 2019


Duration : Permanent – Direct Hire

Job Description:

The Site Quality Assurance Manager will assume overall responsibility for the ongoing development and maintenance of the Quality Management System within the contract logistics business unit(s). This role will oversee and manage branch and business unit Quality functions employing knowledge including but not limited to: cGMP's, corporate policies and guidelines, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the functions performed at the assigned business unit(s).

The RPIC / ARPIC will assume full responsibility for all transactions involving precursors.

The QPIC / AQPIC will assume responsibility for all transactions involving controlled and targeted substances.

Duties and Responsibilities

• Manage, train, assign, schedule, coach and develop QA specialists

• Achieve Quality Assurance operational objectives by monitoring and assigning day-to-day activities, identifying and addressing gaps and problems and providing regular feedback to the Director, QA/RA and stakeholders regarding system performance and issues

• Serve as the site Quality Assurance liaison with external clients

• Perform gap analysis and propose action plans to relevant stakeholders to close gaps with the aim to continually improve the performance of the Quality Management System

• Support management within the Corporate QSHE organization while maintaining location compliance to all Federal, Provincial and Local Quality requirements, where applicable

• Actively participate, support, and when required lead, external audits from existing and prospective clients and regulatory bodies

• Maintain compliance and generate metric reports at the local level regarding core Quality functions (recall, quarantine, inbound hold, release requirements, sampling, return disposition, record retention, training, environmental temperature control, pest control, sanitation, preventive maintenance, vendor qualification, client specific requirements, etc.)

• Support, and if required, perform internal self-inspections;

• Support development and implementation of WI's and SOP's using an advanced knowledge of GMP's and industry standards

• Ownership of branch/client specific SOPs

• Performs monthly review of branch/client specific SOPs for expiration dates

• Manage and monitor changes through Change Control program

• Assist in the development of pro-active strategies as preventive measures against potential future issues with systems or processes

• Monitor, Identify and investigate incidents from a quality perspective

• Manage the non-conformity and planned deviation process and oversee the execution of CAPA commitments

• Manage the day to day activities of the QA Specialists including assignment of tasks/duties, monitoring of work quality and productivity

• Responsible to hire, train, evaluate, develop, coach, guide and direct all QA Specialists within the site.

• Other duties as assigned

Professional experience required:

• 8+ years industry experience in Quality Assurance/Quality Control/Regulatory Affairs

• 2+ years industry experience in Medical Device/Pharmaceutical distribution is preferred

• Experience leading small teams will be considered an asset

• Meet Health Canada's requirements to perform RPIC and QPIC responsibilities

Knowledge required:

• Proficiency in Quality Management systems and standards (i.e. GMP, ISO 13485, 14001, 90001, 180001)

• Experience with warehouse inventory management systems. SAP knowledge is considered an asset

• Advanced knowledge and understanding of GMP's, GDP's, licensing, Federal and Provincial regulations and guidelines

Education required:

• Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, Engineering or a related discipline) is required

• Diploma/Degree/Certificate in Quality Assurance is preferred

Skills required:

• Excellent verbal and written communication, presentation and training skills required. Leadership and managerial skills preferred

• Strong computer skills required, including full proficiency with Microsoft Office Suite

• Strong problem solving, organizational and time management skills required; preferred skills include interpersonal and conflict resolution