Primary Job Posting Location:
Burlington, Ontario Canada
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Job Description:
Summary:
The Healthcare Quality Assurance (QA) 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. This position manages communications with internal groups (e.g. Business Development [BD], Operations, Plant Engineering, Industrial Engineering, etc.), clients, and various federal and local agencies and maintaining 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 is responsible for Healthcare Compliance (QA) oversight of the Burlington 2 and Calgary healthcare facilities, including projects, and management of quality team members (Supervisor(s) and/or Specialist(s)
Job Type: Full-Time| Permanent
Location: Burlington, ON
Work schedule: 8:30am to 5:00pm*
Compensation range: $79,512 annually - $89,448 annually
- Flexibility required based on operational needs
Duties and Responsibilities:
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Manage and conduct internal group (e.g., Operations, PE, IE, HR, BD, IT, etc.) consultations and manage investigations and problem-solving regarding healthcare issues to ensure healthcare compliance with rules and regulations.
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Manage and conduct reviews of policies, procedures, regulations, and specific work instructions with clients to determine specialized requirements and to ensure compliance.
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Interact with regulatory agencies to interpret rules and regulations, determine licensure requirements, and submit required reports and correspondence.
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Conduct follow-ups with agencies after inspections and discovery of internal issues to meet respective agency requirements.
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Oversee 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 Operations personnel.
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Manage and implement training programs and materials to train QA and internal clients on SOPs, work instructions, and regulatory topics.
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Manage 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.
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Hold others accountable to established performance levels to achieve individual and group goals.
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Resolve individual and group performance issues in accordance with UPS’s policies and procedures in a timely manner to motivate and foster teamwork.
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Coach others and provide on-going feedback and support to improve performance.
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Manage and perform the gathering of information, scheduling, and preparation and distribution of reports to prepare for internal and client audits.
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Manage and perform internal audits and recording of information and observations to track and trend audit findings, take corrective and preventative action, and maintain proof of audits and documentation.
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Manage and perform gap analyses and documents results to determine and implement corrective actions for deviations.
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Implement and manage change control procedures, training, and audits and participates in writing and revising procedures identified through the validation process to ensure validation is maintained.
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Oversee compliance to facility programs (Ex. Pest control, sanitation, calibration, environmental monitoring, etc.)
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Conduct quality system management reviews at defined intervals.
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Interface with client QA department and attend business reviews to coordinate client activities.
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Prioritize 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.
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Receive environmental control alarms during set after hours coverage periods and guides the actions of partner departments for product protection.
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Other duties as assigned.
Skills Required:
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Excellent organizational and time management skills
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Excellent written and verbal communication skills
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High work standards
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Aptitude with computer applications
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Superior attention to detail
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Superior problem solving abilities including incident investigation and root cause analysis
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Ability to make timely and factual decisions and recommendations
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Ability to provide work direction and instructions to assisting staff
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Good Leadership qualities/good interpersonal skills
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Detailed understanding of supply chain concepts
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Strong knowledge of current GMP and Quality System concepts
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Excellent research, data gathering and benchmarking skills
Education and Experience:
Minimum qualifications:
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Supervisory or management experience in healthcare distribution
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Quality Assurance experience
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B.Sc. Degree in Healthcare related field, or similar relevant education, from a recognized Canadian University (Canadian University recognized equivalency assessment may be accepted)
Additional beneficial experience:
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Able to successfully obtain clear 10-year history police check
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Pharmaceutical, healthcare or food industry experience
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Logistics or distribution environment experience
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Quality Control experience
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Regulatory Affairs experience
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Chemistry lab experience
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QPIC and RPIC designation experience
Measurable Standards:
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Quality of service provided to internal and external clients and their customers
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Quality of written and verbal communications
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Ability to meet deadlines
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Adherence to procedures
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Organization and accuracy of records
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Communications with other departments
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Site compliance to regulations, GMP and approved Quality Systems
Working Conditions:
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Works under office and warehouse conditions.
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Some overtime as required.
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Occasional travel associated with the position.
What we offer:
UPS offers a competitive compensation package which includes benefit options including health and dental coverage, group insurance plan, paid vacation, employee stock purchase plan and an unlimited opportunity to grow within the company.
Our employee benefits include the following:
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Training and Development: UPS provides full training for all positions to ensure safety and compliance to policies and regulations;
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Promotion From Within: UPS is a globally known brand and has expanded in many countries and so UPS offers lots of room for advancement in many areas of the business;
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Employee Discounts: All UPS employees have the chance to take advantage in employee discounts when purchasing UPS merchandise and other brands;
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The above statements are intended to describe the general nature of the work required for the position and are not intended to be an exhaustive list of all duties and responsibilities.
All candidates must successfully complete a series of interviews in order to qualify. Background and reference checks will also be required.
The rate of pay for the successful candidate will range from $79.512,00/year to $89.456,40/year.
UPS is a diverse and equal opportunity employer. Accommodations are available, on request, for candidates with disabilities taking part in the recruitment process. If you are selected to participate in the recruitment process, please advise if you require accommodation for a disability.
