Director, Operations / Production
Terms : Full time
Location : Mississauga, ON
Working Conditions : This position requires 50-80% of the time at a workstation using a computer, with the rest in meetings and consultations. Occasional travel (up to 5%) and irregular hours may be required.
Summary : The Director of Operations / Production oversees all operational activities across manufacturing / production and distribution processes. The role is responsible for ensuring operational excellence, regulatory compliance, and continuous improvement within the company’s manufacturing, supply chain, quality, and logistics functions. The role requires close collaboration with R&D, quality assurance, regulatory affairs, and other key departments to achieve company goals. The ideal candidate has extensive experience in the medical device industry and is skilled at leading cross-functional teams in a highly regulated environment
Job Responsibilities
1. Operational Leadership :
- Leads and manages day-to-day operations, ensuring alignment with corporate objectives and industry regulations, including FDA, ISO 13485, and other applicable standards.
2. Strategic Planning :
Develops and implements operational strategies that support product development, manufacturing efficiency, cost control, and regulatory compliance.Reports on tracking & monitoring of all production / operation schedules to ensure delivery dates are met. Including material inventory management to ensure fulfillment.Monitors and advises on how the operation & production teams are performing and publishes data and reports regarding operational performance against set indicators.Monitors performance to proactively identify & report issues (including efficiency issues) and proposes solutions for production and CMO’s;3. Cross-functional Collaboration :
Works closely with R&D, Regulatory Affairs, Quality Assurance, and other departments to ensure seamless integration of operations across all functions, supporting product innovation and successful market launches.Where appropriate, advises on changes, monitors implementation as well as provides training, tools, and techniques to achieve compliance.Collaborates with staff from various disciplines to lead the group in planning, developing, and reaching consensus on comprehensive production and operations procedures.Works closely with R&D, QA & RA to ensure any & all changes are properly evaluated, all requirements are predetermined, documented & approved, prior to implementation.4. Supply Chain Management :
Oversees procurement, vendor management, and logistics to ensure timely availability of materials, minimizing supply chain risks, and improving cost efficiency.5. Manufacturing Excellence :
Drives operational excellence in GMP manufacturing processes, optimizing production flow, reducing lead times, and increasing output quality to meet both internal and external customer requirements.GMP production / operations : including overseeing the activities associated with transferring & validating products in the GMP suite, or to a contract manufacturer, as well as subsequent manufacturing activities for ongoing planning & production.6. Quality and Compliance :
Stays abreast of all new and evolving medical device regulations to ensure that operations comply with all such relevant regulations; maintaining product quality and safety Oversees team’s efforts for audits, inspections, and continuous improvement in the quality management systems.7. Team Leadership & Development :
Builds, mentors, and leads a high-performing operations team, fostering a culture of accountability, collaboration, and professional development.Identifying and assessing team training needs.Coaching & developing future leaders within the company.8. Financial Management :
Manages budgets, forecasts operational costs, and develops strategies to improve financial performance and reduce costs without compromising quality or compliance.9. Continuous Improvement :
Leads initiatives for process improvement, Lean Manufacturing, Six Sigma, and other methodologies to enhance efficiency, productivity, and innovation within the operations team.10. Risk Management :
Identifies and mitigates operational risks that could impact production timelines, regulatory approvals, or product quality.11. Participates effectively as a member of the management team
Accounts for the outputs of others.Maintains a team of staff capable of producing the outputs required.Provides leadership to staff.Provides a safe and healthy work environment.Demonstrate stewardship of the assets and resources of the organization.Reports immediately to immediate manager, any variances from the target completion date of the tasks, or that the tasks cannot be completed.Works effectively in collaboration with other members of the department, or with managers and staff across the organization with whom tasks must be completed.Works to achieve assigned tasks within the standards required (quality, quantity, time and resources).Performs other duties as assigned by immediate manager.Qualifications
Knowledge / Experience :
At least 15 years’ experience in the biomedical / biotechnology / pharmaceutical company.At least five years of industry experience with a proven track record of streamlining or improving company operations.Strong business acumen with a broad understanding of fundamental business principlesAbility to set overall strategy and drive process improvement.Skills :
Strong interpersonal skills with ability to collaborate and build a consensus in a high-pressure environment.Detail oriented, analytical mindsetExceptional problem-solving skills and ability to “think outside the box”Demonstrated experience with the Microsoft Office software suite (e.g. Excel, WORD, etc).Good interpersonal, written and verbal communication skillsGood negotiation skillsAttributes :
Process orientated, logical, analytical, meticulous, highly organized and able to analyze data & implement solutionsSelf-motivated and self-directedAbility to handle and prioritize multiple tasksAbility to work independently as well as participating in a team of professionalsAbility to respond to urgent situations appropriately by prioritizationAbility to leverage relationships across other business units and with external sourcesAbility to follow-up with individuals without guidanceAccuracy and strong attention to detail is essentialEducation : Minimum a BSc or equivalent undergraduate degree in a scientific area, preferably post-graduate degree
