Manager, QA Operational Quality

Bora Pharmaceuticals; Mississauga; On-site; CAD 91,000 - 114,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Retirement plan

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Job summary

Bora Pharmaceuticals in Mississauga is seeking a Quality Manager to lead the operational quality activities, ensuring product quality and regulatory compliance while guiding a team of quality professionals.

The role oversees deviations, product releases, investigations, and audits, works with customers and regulatory bodies, and drives continuous improvement in a GMP environment. Onsite with flexible hours and a comprehensive benefits package.

Qualifications

• Experience in operational quality assurance or related role.
• Demonstrated ability to lead projects or change initiatives.
• Strong communication with customers and regulatory authorities.

Responsibilities

• Ensure quality of OCL and Solid Dose products manufactured and packaged at Bora Mississauga.
• Oversee release of OCL and Solid Dose products.
• Investigate deviations, identify root causes and implement CAPAs.
• Oversee shift oversight across all site shifts.
• Approve investigations for products and corrective actions.
• Approve periodic product reviews for products.
• Manage site validation program and changes.

Skills

Quality Assurance

Leadership

Regulatory knowledge

Problem solving

Communication

Education

Bachelor's degree in Science

5-10 years pharma experience

Job description

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.

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

Quality Manager is responsible for management of the operational quality activities to ensure product quality and compliance is maintained and to manage staff accountable for operational quality deliverables.

Responsibilities

• Ensure the quality of ointment, creams and liquid (OCL) products and/or Solid Dose products manufactured and packaged at Bora Mississauga.

• Oversee release of OCL and Solid Dose products .

• Responsible for investigation of deviations pertaining to manufacturing, packaging and testing of OCL and Solid Dose products, identifying true root cause of incidents and assigning corrective and preventative actions. Also identifies and investigates trends.

• Oversees shift oversight activities for all shifts on site.

• Approves complaint investigations for OCL and Solid Dose products identifying true root cause of incidents and assigning corrective and preventative actions.

• Approves periodic product reviews for OCL and Solid Dose products.

• Overseas validation program for the site Evaluates and approves planned changes pertaining to OCL and Solid Dose raw materials products processes and equipment.

• Hosts pre-approval inspections for OCL and Solid Dose products and may co-host other inspections and audits. Responds to queries from regulatory authorities, third party auditors and internal auditors.

• Responsible for providing Bora quality oversight for customer recalls of products manufactured packaged by Bora Mississauga.

• Act as a Quality point of contact with Customer.

• Leads, coaches and mentors team.

• Leads staff to optimize operational effectiveness.

• Manages performance process and career development of staff.

Experience & Skills

• Experience in operational quality assurance or related role with similar responsibilities.

• Demonstrated effective management of issues.

• Experience with external communications with customers.

• Sound knowledge of regulatory framework and ability to make informed decisions and release product to market as per GMPs.

• Demonstrated ability to lead projects or change initiatives.

• Demonstrated ability to influence and lead others as well as the ability to make sound quality decisions.

• Strong interpersonal and communication skills.

Education

• Required: Bachelors degree in Science or related field or equivalent on the job experience through years of service.

• Preferred: 5-10 years in the pharma industry.

Working Condition

• 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

Benefits Include:

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 plans with employer contributions

• Paid time off and flexible work arrangements

• Professional development opportunities

• Employee wellness programs and resources

• Employee Assistance Program and Mental Health Resources

At Bora, our values guide everything we do — from how we solve challenges — from how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.
We’re proud to be an equal opportunity employer, committed to building a diverse and inclusive workplace where everyone feels empowered to contribute and grow. We welcome applications from qualified individuals of all backgrounds, experiences, and perspectives.

If you require accommodation during any stage of the application or interview process, or if you’d like to learn more about our accessibility policies, please contact us at [e-mail].