QA Project Manager

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.

Position Status

This is a fulltime permanent and a backfill position. The role is an active, approved vacancy within the organization and is intended to support current staffing needs.

General Description

Lead and manage the activities of the team responsible for successful completion of all Quality related activities to support significant projects including new client on boarding and manufacturing of development, clinical, registration and validation batches.

Key Responsibilities

• Manage the team responsible for the introduction of new clients and products, providing coaching and guidance to ensure correct decision-making.

• Responsible for People management aspects including performance reviews, coaching, work assignments/ work , priorities and to ensure efficient use of team resources e.g. resource capacity and utilization assessments.

• Drive the creation and streamlining systems/processes as required to support CDMO activities.

• Oversee the successful on-boarding of new clients, products, or processes.

• Represent Quality with significant new clients, assisting with negotiation of Quality Agreements.

• Support review of batch records (master or executed) for non commercial and first commercial lots along with associated documentation, disposition of batches (non commerical), and deviation investigations and CAPAs.

• Support the quality aspect of planned changes raised to support non-commercial or commercial activities , ensuring compliance to procedures and regulations.

• Provide final quality approval on documentation generated to support projects. This will include technical reports, validation/verification reports, analytical methods, specifications, risk assessments etc.

• Host Client and/or Regulatory inspections as required.

• Approve documentation/declarations to support Client registration activities.

• Ensure smooth transition of all necessary activities from projects to routine business (up to and including the first commercial lots).

Experience & Skills

• Minimum 10 years’ experience within Quality or Quality Operations primarily in the pharmaceutical industry. Similar experience in an equivalent industry would be considered.

• Manufacturing experience is an asset.

• Demonstrated ability to coach and develop people.

• Demonstrated understanding of the regulatory framework and current industry quality standards from development to commercialization.

• Experience in interpreting regulations as it relates to all different stages of drug manufacturing.

• Demonstrated ability to develop and lean processes.

• The ability to influence, problem solve and support other members of your team.

• Demonstrated ability to make sound quality risk-based decisions in a fast paced environment.

• Computer literate with excellent writing skills and communication skills.

Education

• Required: Bachelor’s degree in science or related field and/or on the job experience in pharmaceuticals Area(s) of Specialization.

Working Conditions

• Must be able to work with a computer for several hours per day.

• Flexibility with Onsite Work Schedule and Occasional Extended Hours.

Additional Information

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.

Compensation Range

$91,410 - 114,260