Manager, QA Operational Quality
About The Position
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 fulltime permanent and a backfill position. The role is an active, approved vacancy within the organization and is intended to support current staffing needs. 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.
Requirements
- 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.
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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
