Healthcare QA Associate Manager

UPS•Burlington, ON

3d•Onsite

About The Position

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).

Requirements

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
Supervisory or management experience in healthcare distribution
Quality Assurance experience
B.Sc. Degree in Healthcare related field, or similar relevant education, from a recognized Canadian University (Canadian University recognized equivalency assessment may be accepted)

Nice To Haves

Able to successfully obtain clear 10-year history police check
Pharmaceutical, healthcare or food industry experience
Logistics or distribution environment experience
Quality Control experience
Regulatory Affairs experience
Chemistry lab experience
QPIC and RPIC designation experience

Responsibilities

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.
Manage and conduct reviews of policies, procedures, regulations, and specific work instructions with clients to determine specialized requirements and to ensure compliance.
Interact with regulatory agencies to interpret rules and regulations, determine licensure requirements, and submit required reports and correspondence.
Conduct follow-ups with agencies after inspections and discovery of internal issues to meet respective agency requirements.
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.
Manage and implement training programs and materials to train QA and internal clients on SOPs, work instructions, and regulatory topics.
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.
Hold others accountable to established performance levels to achieve individual and group goals.
Resolve individual and group performance issues in accordance with UPS’s policies and procedures in a timely manner to motivate and foster teamwork.
Coach others and provide on-going feedback and support to improve performance.
Manage and perform the gathering of information, scheduling, and preparation and distribution of reports to prepare for internal and client audits.
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.
Manage and perform gap analyses and documents results to determine and implement corrective actions for deviations.
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.
Oversee compliance to facility programs (Ex. Pest control, sanitation, calibration, environmental monitoring, etc.)
Conduct quality system management reviews at defined intervals.
Interface with client QA department and attend business reviews to coordinate client activities.
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.
Receive environmental control alarms during set after hours coverage periods and guides the actions of partner departments for product protection.
Other duties as assigned.