Operations Director Medical Device jobs

The Healthcare QA Senior Manager – Importer of Record is responsible for leading regulatory and quality strategy for UPS Healthcare’s consulting services in Canada. This role ensures compliance with Health Canada regulations while supporting pharmaceutical clients with regulatory guidance, audits, and quality systems. The position combines leadership, regulatory expertise, and client-facing consulting to support compliant importation and distribution of healthcare products. It also plays a key role in audit readiness, licensing, and continuous improvement of QA practices. The individual will act as a subject matter expert and help scale UPS Healthcare’s consulting capabilities.

Job Type: Full-time | Permanent

Schedule: Monday to Friday | 8:30 to 17:00

Location: Vaughan, ON

Modality: On-Site

Quality Regulatory Consulting Services

• Responsible for Managing RA/QA strategy and direction for Regulatory Consulting Services.
• Manage Team for consultative practice development (IOR, mapping & validation, compliance audits, GMP training, etc.).
• Develops and integrates quality policies and procedures supporting Consulting Services ensuring compliance with current regulations.
• Subject Matter Expert in Health Canada regulations and guidelines ensuring awareness of upcoming regulatory changes impacting Consulting Services activities. Implement changes as needed to ensure compliance.
• Ensure UPS Healthcare meets current regulatory and quality standards for Consulting Services.
• Ensure preparedness and host Health Canada and other regulatory agency or Client audits for Consulting Services activities. Implement actions as required for any observations.
• Provides regular updates to Sr. Director on Consulting Services.
• On regular occasion, performs external environmental scanning for trends in markets where Ups Healthcare could or does operate for changes in regulatory healthcare requirements.
• Prepare and oversee the Company’s periodic and ad hoc regulatory filings such as license applications, comments or other submissions required to support Consulting Services. Maintain regulatory licenses and all foreign sites in a valid state.
• Identify staffing and training needs to ensure compliance and sustainability of Regulatory Consulting Services.
• Interact with Regulatory Consulting Services Clients and act as subject matter expert to support regulatory and quality compliance of their current and new products in Canada.
• Interact with Health Canada as needed to support Regulatory Consulting Services. Maintain positive relationships with Health Canada representatives.
• Participates in developing Regulatory Consulting Services budget and business plans on a yearly basis.
• Prepares monthly billings for Consulting Services ensuring hours and activities are tracked. Answer any questions related to billings and resolve issues.
• Supports the integration of Quality policies for all entities utilizing a consultative manner.
• Provides counsel for UPS Healthcare entities on RA/QA policy matters, regulatory filings, audits, license requirements, applications and maintenance, high-level client interactions, etc.
• Supports client or regulatory escalations related to quality systems, procedures, and non-conformities.
• Bring creativity and passion to the organization and its services and possess a broad institutional perspective while embracing change and innovation, including managing the Company’s public statements or comments in respect of regulatory affairs.
• Prepare or oversee the preparation of consolidated RA/QA reporting (quality metrics, executive reviews, scorecards, etc.) to provide management insight into potential risks/opportunities to forecast or plan.
• Active participation with healthcare industry organizations and associations.
• Supports the Sr. Director or their designate on QA and Regulatory affairs related due diligence associated with mergers and acquisitions.

Core Competencies:

Teamwork

• Encourages team work departmentally and cross functionally
• Actively participates with peers and other departments to develop solutions, respond to inquiries and encourage open dialogue.

Problem Solving

• Anticipates problems, considers solutions as per the organization, clients, regulatory authorities, vendors, other individual departments, and fiscal budget before making decision.

Leadership

• Links mission and vision to strategies and corporate goals.
• Acts as a role model and mentor for new and less experienced associates.

Communication

• Identifies and presents information that will motivate, persuade, engage or influence others.
• Considers the specific receivers’ communication style and needs while responding professionally and factually.

Change Management

• Leads the translation of broad organizational strategies into specific directions and goals.
• Anticipates requirements to implement change.
• Is prepared to respond to the various reactions to change to support an engaged workforce.

Execution

• Consistently results driven.
• Takes responsibility and ownership of assigned tasks to ensure financial and service goals are met.
• Accepts responsibility to make decisions under pressure to achieve results.
• Makes continuous improvement recommendations while considering client satisfaction and business results.

Decision Making

• Makes timely, informed decisions utilizing the facts, goals, constraints, and risks.
• Ensures that appropriate parties are consulted before implementing decisions that impact other business units or client.

Client Orientation Internal and External

• Champions and supports continuous improvement initiatives that help transform client satisfaction into client loyalty.
• Takes a consultative approach, developing mutual understanding with clients regarding their current and future business needs in order to meet and exceed clients’ needs.
• Coaches team on the client’s specific requirements/needs to ensure understanding of individual impact on client retention.

Planning and Organization

• Takes a proactive approach to planning, identifying issues.
• Weighs risks and builds appropriate contingencies into processes.
• Determine appropriate methods, procedures, resource allocations to achieve long-term objectives.

Qualifications:

• 10 years of senior QA and/or operational leadership experience in the healthcare sector; preference provided to the pharmaceutical industry
• Holds an accredited Bachelor of Science degree. Post Grad degrees are an asset.
• Expert knowledge of Good Manufacturing Practices Guidelines (“GMP”) in Canada and working knowledge of, GDP, cGMP, cGDP regulations in Europe and the United States
• Proven executive level experience in planning and managing at both the strategic and tactical levels
• Proven executive level experience supporting supply chain solutions and services focused on the healthcare sector including pharmaceutical manufacturers, 3PLs or Rx wholesalers/distributors and regulatory agencies such as Health Canada, FDA or European Medicines Agency
• An expert understanding of Company’s market: products, players, technologies, trends, and contacts in related markets.
• Proven expertise and experience influencing and asserting strategic direction.
• Expert level of knowledge of healthcare quality systems including root cause investigation and analysis, corrective and preventive actions, change control, documentation standards, validation protocols, training and regulatory requirements
• Expert level of business and financial acumen.
• Places a high value on teamwork through positive relationships and soliciting feedback from all subject matter experts.
• Strong analytical skills and a data driven mindset
• Consistently supports and exemplifies the organizations values in day-to-day environments.
• Communicates through positive and constructive methods to drive the business goals.
• Promotes and leads a philosophy of acceptance to change management through strategic long term and short-term planning.
• Values strong mutually beneficial relationships with internal and external partners.

Additional Requirements:

• Travel as required with possible overnight stay as business needs dictate
• Excellent command of Microsoft Office, Excel, Word, PowerPoint
• Excellent communication and people skills
• Proven experience utilizing various Quality Management Systems
• AI, Power Apps is an asset

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.
• 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;

__________________________________

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.

Pay: $104,964.00-$118,047.00 per year

Work Location: In person