Job Description

Primary Job Posting Location: Burlington, Ontario Canada Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow\xe2\x80\x94people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. : Summary: The Healthcare Quality Assurance (QA) Associate Manager is responsible for ensuring compliance with the regulatory requirements of the applicable national regulatory authority and to ensure uniform interpretation and implementation of the Healthcare Quality System across geographically distributed operations. They manage communications with internal groups (e.g. Transportation, Business Development [BD], Operations, Building & Systems Engineering, Industrial Engineering, etc.), clients, and various federal and local agencies, and maintain procedures and documents to ensure compliance to the applicable regulatory requirements. The Healthcare QA Manager oversees GMP compliance, minimizes risks associated with transporting healthcare products, oversees internal, client, and agency audits, and ensures that the validation of facilities, systems and supporting equipment are completed as applicable. This position manages Supervisors and/or Specialists. : Duties and Responsibilities: Manages and conducts internal group (e.g., Transportation, Operations, BaSE, IE, HR, BD, IT, etc.) consultations and manages investigations and problem-solving regarding healthcare issues to ensure healthcare compliance with rules and regulations. Interfaces with client QA departments and attends business reviews to coordinate client activities and provides quality updates. Manages and conducts reviews of policies, procedures, regulations, and specific work instructions with clients to determine specialized requirements and to ensure compliance. Interacts with regulatory agencies to interpret rules and regulations, determine licensure requirements, and submit required reports and correspondence. Conducts follow-ups with agencies after inspections and discovery of internal issues to meet respective agency requirements. Oversees the writing and revision of standard operating procedures (SOPs) and/or work instructions (WIs) to incorporate agency regulations and ensure proper procedures are followed by supporting department personnel. Manages and implements training programs and materials to train QA and internal clients on SOPs, work instructions, and regulatory topics. Manages resources and people processes (e.g. Performance Management, Career Development, Training, Staffing, etc.) to ensure the day to day administration of processes and formal procedures. Holds others accountable to established performance levels to achieve individual and group goals. Resolves individual and group performance issues in accordance with UPS\xe2\x80\x99s policies and procedures in a timely manner to motivate and foster teamwork. Coaches others and provides on-going feedback and support to improve performance. Manages and performs the gathering of information, scheduling, and preparation and distribution of reports to prepare for internal and client audits. Manages and performs external audits of suppliers, including tracking of audit finding corrective action completion, and maintenance of audit documentation. Manages and performs gap analyses and documents results to determine and implement corrective actions for deviations. Implements and manages change control procedures, training, and audits and participates in writing and revising procedures identified through the validation process to ensure validation is maintained. Conduct quality system management reviews at defined intervals. Prioritizes complex, material, and/or multi-functional risks to the enterprise; coordinates and provides governance over risk treatments; develops business continuity plans to improve preparedness and response capabilities. Overseeing supplier compliance to programs (Ex. Pest control, sanitation, calibration, environmental monitoring, etc.). Other duties as assigned. Skills Required: Excellent organizational and time management skills Excellent written and verbal communication skills High work standards Aptitude with computer applications Superior attention to detail Superior problem-solving abilities including incident investigation and root cause analysis Ability to make timely and factual decisions and recommendations Ability to provide work direction and instructions to assisting staff Good Leadership qualities/good interpersonal skills Detailed understanding of supply chain concepts Strong knowledge of current GMP and Quality System concepts Excellent research, data gathering and benchmarking skills Education and Experience: Qualifications: 5 years experience in pharmaceutical or healthcare industry in a quality related role, preferably in the capacity of a quality manager Quality Assurance experience B.Sc. Degree in Healthcare related field from a recognized Canadian University (Canadian University recognized equivalency assessment may be accepted) Additional beneficial experience: Able to successfully obtain clear 10 year history police check Logistics or distribution environment experience Quality Control experience Regulatory Affairs experience Chemistry lab experience Food industry experience QPIC and RPIC designation experience Measurable Standards: Quality of service provided to internal and external clients and their customers Quality of written and verbal communications Ability to meet deadlines Adherence to procedures Organization and accuracy of records Communications with other departments Site compliance to regulations, GMP and approved Quality Systems UPS Canada is a diverse and equal opportunity employer. Please advise our HR representatives if workplace accommodation is needed. Thank you for your interest in UPS Canada.