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Job Description:

Position Overview:

UPS Healthcare Global Director of Standards & Systems will be responsible for leading and overseeing all aspects of the healthcare quality systems and standards related to GxP across our organization. This critical role requires a strong background in healthcare quality management, deep knowledge of regulatory requirements, and a proven track record in leading and maintaining quality systems within a global environment. You will play a pivotal role in ensuring our compliance with applicable healthcare regulations and industry best practices while driving continuous improvement initiatives to enhance our quality processes.

Our dynamic and growing organization as the Global Director of Standards & Systems and play a key role in shaping and ensuring the quality and compliance of our global healthcare operations.

Main Purpose

The Quality Management System is a collective, interrelated and interactive group of defined processes and procedures that must be implemented and adhered to achieve and maintain a high-quality standard. These processes and procedures incorporate the current requirements of Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Clinical Practices (GCP), Good Storage Practices (GSP), ISO 13485 and ISO 9001 accredited programs and adherence to UPS Healthcare Quality Standards (SOPs), local laws and authority regulations, and customer requirements.

Responsibilities:

• Maintain and own the global quality system and standards strategy roadmap for GxP compliance across all relevant functions and business units.
• Maintain quality standards, policies, and procedures in alignment with global regulatory requirements and industry guidelines.
• Lead the management of quality systems, including document control, change control, deviation management, risk management, and Corrective and Preventive Actions.
• Drive initiatives to enhance operational efficiency, streamline processes, and optimize resource allocation while maintaining the highest quality standards
• Ensure targets are achieved through effective quality performance monitoring, measurement, and analysis and reporting. Identify Quality KPIs, collate KPI data and reporting. Produce KPI metrics to monitor and drive continuous improvement. Collaborate with cross-functional teams to develop and deliver training programs on quality systems, GxP regulations, and compliance requirements.
• Drive vendor management and management of third-party auditors regarding quality system matters and inspections.
• Stay abreast of evolving regulatory guidelines and industry trends to proactively assess and address potential impacts on the organization's quality systems.
• Provide Quality leadership and oversight of the QA Managers, QA Supervisors and QA Specialists to ensure consistent implementation of and compliance to the UPS Healthcare Quality Management System.
• Provide support (when needed) to oversee, review and approve locations Validation, Calibration, and Preventative Maintenance programs to assure consistent implementation of the Marken programs regionally in conjunction with the global validation team.
• Responsible for attending and supporting inspections and visits, performed by the local authorities and certified bodies (e.g. ISO) as required to meet business needs.

Service:

• In conjunction with the VP of Healthcare Compliance, Quality & Regulatory Affairs manage strategic quality initiatives to support business growth.
• Maintain quality service by establishing and enforcing organizational standards
• A member of the Quality Council
• Supporting the VP of Healthcare Compliance, Quality & Regulatory Affairs to manage the P&L for Quality
• The primary lead for Corporate Internal Audits

General:

• Ensure compliance with national and international standards and legislation
• Ensure timely and efficient management of records pertaining to the Quality Assurance Team.
• Adhere to Good Manufacturing / Distribution / Clinical Practices
• Travel as reasonably requested by the Line Manager for the performance of duties.
• Undertake any other reasonable duties at the request of the Line Manager
• To support daily tasks and issues as needed.
• To always adhere to all company Policies.

Qualifications:

• Strong leadership skills with the ability to drive change, influence stakeholders, and foster a culture of quality and compliance.
• Financial Acumen
• Excellent problem-solving and decision-making abilities, with a keen attention to detail.
• Exceptional communication and interpersonal skills, capable of effectively engaging with individuals at all levels of the organization.
• Experience in managing and leading global teams across multiple locations and time zones is highly desirable.
• Professional certifications in quality management (e.g., Certified Quality Auditor, Certified Quality Manager) are advantageous.
• Bachelor's or advanced degree in a scientific or technical discipline.
• Extensive experience (7+ years) in quality management, preferably within the pharmaceutical, biotechnology, or medical device industries.
• In-depth knowledge of GxP regulations, such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and their application in a global setting.
• Proven experience in developing, implementing, and managing quality systems in accordance with regulatory requirements and industry best practices.

Additional Information:

• Job Grade: 40F
• UPS Healthcare Facility Location: Burlington, Canada
• Relocation Assistance Not Offered: Candidate must report to the UPS Healthcare Facility in Burlington, Canada. Candidates not located in the listed location must be willing to self-relocate.
• Application Deadline: Wednesday April 30th - 11:59 p.m. ET

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.