Healthcare Quality Assurance & Regulatory Affairs Sr Director

Primary Job Posting Location:

Burlington, Ontario Canada

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Job Description:

Main Purpose:

The Sr Director Quality Assurance & Regulatory Affairs (Sr Director QARA) CANADA is responsible for the oversight of Quality Assurance and Regulatory Affairs activities for UPS Healthcare Canada logistics & distribution including UPS SCS Inc., Accuristix and LSU facilities. This position is responsible for the maintenance of GMP & GDP compliance as well as compliance with regulatory standards, corporate policies and procedures as well as client requirements. This position is responsible to attend and support inspection and visits, performed by the local Authority and certifying body.

Job Type: Full-Time| Permanent

Location:  Burlington, ON

Work schedule: Monday to Friday | 8:00am to 5:30pm

Compensation range: $8.474/monthly - $9.840/monthly

Main Duties and Responsibilities:

The Sr Director QARA, is responsible for supporting the UPS Healthcare Canada logistics and distribution operations and discrepancy/ issue management, Corrective and Preventive Action (CAPA) systems, change control and the management of change, performance of audits, and the management and reporting of key quality performance indicator targets (KPIs) for UPS Healthcare Canada logistics & distribution facilities and issue escalation to the UPS Healthcare Canada VP QARA.

They will also be expert on UPS Healthcare operational SOP requirements and associated documentation, deliver training/ development of staff on SOPs and processes, manage UPS Healthcare training records (internal staff and 3rd party providers), monitor quality performance, upgrade CAPA quality and timeliness, perform Global GMP (Good Manufacturing Practices) GDP (Good Distribution Practices) quality audits, manage external audits of UPS Healthcare Canada by our clients and perform audits of 3rd Party Service providers in conjunction with the UPS Healthcare Approved Supplier (ASL) team.

• Provide Quality leadership and oversight of the UPS SCS Inc., Accuristix and LSU Directors, Sr QA Managers, QA Managers and QA Associates/Specialists to ensure compliance to the UPS Healthcare Quality Management System at all locations in Canada.
• Escalate concerns and critical issues to the UPS Healthcare Canada Vice President QA & RA.
• Ensure targets are achieved through effective quality performance monitoring, measurement, analysis and reporting.
• Effectively interact with Quality Associates, Quality Managers, Sr Quality Managers, Directors and Operations stakeholders to maintain quality and ensure compliance with quality objectives.
• Ensure effective controlled document review and approval.
• Ensure Narcotics/Controlled Substances, Precursor and Cannabis Licenses as applicable are maintained and renewed according to the regulations. Ensure all site activities comply with the requirements of these licenses.
• Perform internal audits, host client audits as well as perform audits of external service providers as part of the vendor selection (when required) and management process, and in doing so complete audit reports and any relevant audit follow up.
• Manage discrepancies, issues, and CAPA plans, collate CAPA data, and identify trends and quality improvement. Escalate trends to UPS Healthcare Canada Vice President QA & RA.
• Review and approve issues, CAPAs, changes controls as required by procedures.
• Identify relevant quality related training needs for employees and deliver training where required.
• Collate and report Quality KPIs and drive continuous improvement.
• Ensure compliance with Validation, Calibration, and Preventative Maintenance programs to assure consistent implementation of the UPS Healthcare programs in conjunction with the global validation team.
• Responsibilities related to the Canadian Quality Directors, Managers and Quality Associates
• Guarantee the correct training of these positions.
• To conduct at least a “1 to 1” meeting with direct reports at least once a month.
• To define the Professional Goals annually.
• To support them in daily tasks and issues (not limited to the Quality Area).

Service:

• In conjunction with the UPS Healthcare Canada Vice President QA & RA, manage strategic quality initiatives in order to support business growth.
• Maintains quality service by establishing and enforcing organizational standards

General:

• Bachelor’s degree or the equivalent combination of relevant education and professional experience
• 7+ years of pharmaceutical/biotechnology industry experience including Quality
• Deep knowledge and understanding of GMP & GDP
• Manufacturing, Logistics and Project Management experience a plus
• Ensure compliance with national and international standards and legislation
• Ensure timely and efficient management of records pertaining to the Quality Assurance Team.
• Travel as reasonably requested by the Quality Management for the performance of duties.
• Undertake any other reasonable duties at the request of the Quality Management.
• To support daily tasks and issues as needed.
• To adhere to all company Policies at all times.
• ASQ or ISO Certification is an asset.

Acknowledgement:

By signing in eQMS the jobholder agrees to comply with the requirements of the job description, and understands that failure to comply with the requirements may result in disciplinary action.

By signing in eQMS the line manager confirms the job description is a true and accurate reflection of the duties and responsibilities of the role, which has been fully explained to- and understood by- the jobholder.

Any changes to the job description must be agreed by the line manager and the jobholder

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:

• Training and Development: UPS provides full training for all positions to ensure safety and compliance to policies and regulations;
• Generous Benefits Package: All UPS Canada employees have extended health, dental, and vision benefits. UPS Canada TSG employees have a Defined Contribution Pension Plan (DCPP) with calibrated Company-matching;
• 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;
• 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.

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.