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Healthcare QA Associate Manager

Permanent Primary Location: BURLINGTON, Ontario - Canada Job ID R21006675 Date posted 09/21/2021 Zip Code L7L 0A7

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Job Description:

Job Description 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. 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 Associate 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 healthcare facilities, and manages Supervisors and/or Specialists.

Job Description:

Duties and Responsibilities:

  • Manages and conducts internal group (e.g., 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 Operations 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’s 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 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.
  • 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 compliance to facility programs (Ex. Pest control, sanitation, calibration, environmental monitoring, etc.)
  • Receives environmental control and security alarms during set after hours coverage periods and guides the actions of partner departments for product protection.
  • 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:

  • 2 to 5 years’ experience in pharmaceutical or healthcare industry in a quality related role, preferably in the capacity of a quality leader, supervisor or 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

Working Conditions:

  • Works under office and warehouse conditions.
  • Some overtime as required.

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.

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