Project Manager, Operations Management, Regulatory Compliance Specialist

About Bora Bora Pharmaceuticals

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world.

Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

This is a permanent full-time position part of our PDS (Pharmaceutical Development Solutions) Team. This job posting reflects a current vacancy within the organization. The position is active, approved, and intended to be filled as part of our staffing needs. This posting is for an existing and currently open position.

Oversee, monitor and report on Projects across the Mississauga Manufacturing site. Responsible for projects including:
New Product transfers into Bora Mississauga including managing schedule and budget. New market launches or product line extensions for existing products ntify where opportunities lie for increased revenue within projects. Manage requests and prioritization for new projects by aligning resource across the site, identifying future requirements. Manage project budgets to target. Pass on information required, as key site contact, for new business proposals when requested by business development.

Ensure GMP requirements are met for all group activities.

• Manages project scope, budget and timelines and in some instances, manage Project Coordinators.
• Be the main point of contact with external clients and within the site for relevant projects.
• Host client visits.
• Prepares project proposals and plans.
• Chair regular client/Bora meetings and exhibit clear communication to clients.
• Identifies and obtains appropriate project resources.
• Monitors and reports project progress at regular intervals to key stakeholders (on site) and clients.
• Leads cross functional project teams to ensure project deliverables and timelines are met.
• Ensures all activities are completed in a compliant manner and adheres to cGMP requirements.
• Develop new Business proposals for clients.

Minimum 3 years Pharma experience across a range of functions to understand the end to end supply chain from development to commercial manufacturing. The ability to lead meetings, communicate effectively with project teams, clients and key stakeholders. Good relationship management to interact with internal and external customers. Good knowledge of cGMP and global regulatory standards required. Solid understand of manufacturing, packaging and early stage development.

Detailed oriented.

Required:

Bachelor of Science. PMP Certification. Preferred:
Science/Project Management.

Mainly office environment with minor visits to production area to host clients.

In accordance with Ontario's pay transparency requirements, candidates will be notified when they are no longer under consideration or once the vacancy is closed. Updates regarding application status may be communicated via email or through the online applicant profile, where applicable. As part of our recruitment process, we may use technology-assisted tools, including automated systems, to support the review and assessment of applications.

These tools do not make final hiring decisions. All decisions related to screening, interviewing, and selection are made by our Talent Acquisition and hiring teams.

$81,240 - $101,550

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings…