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Senior Manager, Production (New Beta Innovation Canada Limited)
Company | BCJobs |
Address | Burnaby, British Columbia, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Technology, Information and Internet |
Expires | 2023-09-05 |
Posted at | 9 months ago |
About The Company
- Responsible for all aspects of GMP production ensuring products meet production schedule, quality standards and regulatory compliance
- Ensure quality systems are aligned with corporate to enable a common approach of quality initiatives/knowledge sharing and strengthen NBI global regulatory compliance
- Participate in management reviews of process performance, product quality and advocating continual improvement
- Ensure company’s Quality Management System (QMS) is effectively implemented and followed
- Ensure timely and effective communication of quality issues to the site Qualified Person (QP), Quality Assurance management (QA) and escalation to corporate management
- Manage all production related plan programs and team activities to meet tight targets and schedule
- Responsible for leading improvements from end-to-end of production line
- Lead, manage and coach Production team with high level of engagement and achievement
- Ensure site manufacturing comply with regulatory commitments in NBI dossiers per CMC section of marketing applications
- Ensure budgets, schedules and performance requirements are met and delivered on time/in full and at the right cost
- Provide support and participate in material supplier qualification and contract manufacturers qualification activities as deemed necessary by Quality Assurance
- Responsible for the performance management, professional growth and development of the team
- Develop and/or monitor Key Performance Indicators and determine overall manufacturing support including team resource and equipment planning to meet production schedules
- Implement consistent and accurate reporting of potential risks and quality or compliance issues to corporate management
- Participate in the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality
- Ensure that products are produced and stored according to the appropriate documentation or procedure in order to obtain the required quality
- Perform other duties as required
- Develop and approve the instructions and SOPs relating to production operations according to corporate and regulatory requirements and ensure their strict implementation
- Strong sense of pride in ownership and quality of work
- Work efficiently with the ability to be innovative and identify creative solutions
- Good working knowledge of GMP and regulatory requirements for products in major markets (such as FDA, EMA, HC, TGA)
- Degree in pharmaceutical, biotechnology, biochemical engineering or equivalent life sciences discipline. The degree should be issued by a Canadian university or recognized by a Canadian university or Canadian accreditation body
- High proficiency in MS Word and good writing skills
- Flexible and adaptable to changing circumstance and challenges
- Knowledge with aseptic processing is a must
- Excellent interpersonal skills, ability to work independently and in a team environment
- Ability to effectively problem solve, manage resources and work under pressure to maintain continuous operations
- 10+ years relevant hands on downstream processing experience in biological manufacturing industry with a minimum of 5+ years of managerial experience
- Ability to strategize, and implement department plans
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