- December 13, 2017
Research and Development Manager, Quality Assurance
Principal Duties and Responsibilities:
- Provide leadership to team through employee development and performance management as well as establishing a culture of Quality.
- Provide leadership by coaching and ensuring knowledge sharing within R&D and R&D QA in order to establish/strengthen a culture of Quality and optimize the effectiveness of compliance in R&D Operations
- Provide leadership for the Development, maintenance and monitoring of the Quality Systems in R&D to ensure compliance to cGMP and regulatory requirements
- Ensure R&D is compliant to the processes and systems associated to SOP and Documentation control
- Ensure initiation and proper processing of Change Controls, Deviations and CAPAs and their completion in a timely manner.
- Oversee the product release activities for stability/submission batches
- Ensure due diligence on vendor selection and approval process in collaboration with commercial QA
- Ensure that R&D is compliant to the processes and systems associated to training requirements, Change Control and Stability Programs
- Ensure that SOPs for all applicable elements of the Quality systems are established and current. Develop new SOPs if required.
- Ensure a comprehensive and thorough Risk Management process is established and properly implemented throughout analytical and product development activities that will support a robust product lifecycle
- Assist R&D with Quality by Design (QbD) approach to establishing preliminary process capability factors, performance indicators, identifying critical process parameters and critical quality attributes in product development
- Review Deficiency Letter(s) (DL) and responses to assess compliance and impact on Commercial Quality Operations
- Interact with internal groups including Project Management, Materials Management, Regulatory Affairs, Quality Control, Production and Commercial QA and represent R&D QA during product commercialization activities (product transfer from R&D to Commercial Quality).
- Assure analytical method and product transfer activities are in compliance with cGMP
- Ensure harmonization of processes and best practice of R&D QA between locations
- Support the self- inspection program
- Participate in Regulatory Audits.
- Other duties as assigned
Knowledge, Skills and Abilities
- B.Sc. Chemistry or other associated field
- Minimum 8-10 years’ experience in Quality Assurance or Quality Control in the pharmaceutical or related industry environment.
- Minimum 5 years’ experience the supervisory/management level
- Minimum 2-3 years’ experience in R&D QA in the pharmaceutical industry
- Experience in dealing directly with Regulatory Agency officials (Health Canada, USFDA,)
- Sound knowledge and application of Health Canada and FDA regulations
- Strong knowledge of R&D processes applicable to Pharmaceutical Industry
- Strong knowledge of pharmaceutical operations
- Strong organizational, coaching, communication (written and verbal), technical, time management and multi-tasking ability
- Strong laboratory knowledge
- Good interpersonal and negotiating skills
- Non-routine and complex problems
- Problem associated to complex R&D environment
**Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.*
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