Manager, QA Operational Quality

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

Benefits offered by this job

Competitive salary and incentives

Comprehensive health coverage (medical

Dental, vision insurance

Retirement savings plan

Paid time off and flexible work

Professional development opportunities

Employee Wellness programs

Job summary

Bora Pharmaceuticals in Mississauga, Canada seeks a Quality Manager to oversee operational quality and ensure GMP compliance across OCL and Solid Dose products. You will lead investigations, CAPA, and recalls while guiding cross-site quality improvements.

Role requires 5–10 years in pharma quality, strong leadership, and excellent communication with regulators and customers. Onsite, with flexible hours and career development opportunities.

Qualifications

• Bachelor's degree in Science or related field required.
• 5–10 years in pharma quality operations.
• Experience with regulatory audits and recalls.
• Strong communication and leadership skills.

Responsibilities

• Lead quality assurance activities to ensure product quality and GMP compliance.
• Manage investigations and CAPA for deviations at Mississauga site.
• Oversee shift oversight and complaint investigations.
• Host or co-host inspections by regulators.
• Provide quality oversight for customer recalls.

Skills

Operational QA

Quality management

GMP compliance

Regulatory communication

People leadership

Education

Bachelor's degree in Science

Job description

About BoraBora 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 StatusThis 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 DescriptionQuality 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.ResponsibilitiesEnsure 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 & SkillsExperience 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.EducationRequired: 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 ConditionFlexibility with Onsite Work Schedule and Occasional Extended Hours.Additional InformationIn 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 - 114,260Benefits 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 ResourcesAt Bora, our values guide everything we do — from how we solve challenges to 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].