QA Associate Manager

**Primary Job Posting Location**:
Burlington, Ontario Canada

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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. 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.

**Job Description**:
**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’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 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

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**: