Quality Assurance – Director
The QA department is responsible for Product Quality Assurance drug/device combination products. These activities comprise of disposition decisions for products, materials, protocols for clinical investigations, and pilot plant and laboratory support for all facilities. In addition, the department has responsibility for corresponding satellite functions. The basic functions are to assure that products (including API, drug product and finished packaging and labeled supplies) and data provided by the R&D organization are compliant with worldwide quality and regulatory requirements. We have a challenging opportunity for a Director, QA based in Montreal, Quebec, Canada reporting to the Director, Regulatory Affairs and compliance.
Key Responsibilities Include:
- Implement combo product quality system requirements. Ensure alignment and integration with existing pharma processes, where appropriate. Demonstrate expert knowledge of global regulations.
- Act as advisor to management and customers. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Develop organizational model for combination product support.
- Ensure QA capabilities exist to support this model.
- Identifies and procures resources to support divisional implementation and support of combination product regulations and new product introductions.
- Works with management and with the department to achieve related goals and strategic initiatives.
- Provides consultation and training on combination products to internal and cross-functional groups.
- Responsible for supporting activities for the Combination Product Regulations with Pharmaceutical products.
- Support the strategic direction to ensure business objectives are met to support and sustain the Combination Product regulations with Pharmaceutical products.
- Complete quality assurance activities to develop, implement and sustain required device regulations to comply with Combination Product Regulations, Corporate, Division and Site policies.
- Assure proper integration and support of device regulations, drug regulations
- Manage and oversee the interrelated function activities related to design control with GPO Manufacturing Science and Technology (MS&T) / QA, Supply Chain, Regulatory Affairs and other QA functions
- Partner with Third Party Vendors/Manufacturers to ensure that devices are in compliance with all Company and Regulatory Agency standards.
- Support new product development for combination products. understanding of the pharmaceutical product development cycle.
- Knowledge of regulations and standards affecting devices, biologics and pharmaceutical products.
- Knowledge of ISO standards, US Code of Federal regulations, and the EU regulations.
- Understands impact of specific area system changes to other quality systems as well as changes within division requirements and impact to specific area of control.
- Conflict resolution skills including persuasive management techniques required.
- Strong oral and written communication skills needed.
- Excellent interpersonal skills required includind proof of very good people management skills
- Makes critical, creative and strategic decisions as a result of rapid analysis of available information including risk-assessment for the patient and for the business.
- Responds quickly to unplanned events, technical issues and changing needs from development programs by making sound quality judgment from complied factual data provided by the different functional areas, each presenting varied viewpoint of regulatory requirements or project needs and requirements.
- Leadership of other technical professionals and experience in leading global cross-functional teams with results-orientation.
- Skilled in the initiation, selection, coordination and management of projects and have ability to resolve unusually complex technical problems by providing solutions that are highly innovative.
- Work with external and internal partners to establish best in class practices for combination products.
- Represent the company on External Industry groups where appropriate. Represent company as the combination products Quality Assurance subject matter expert during internal and external regulatory inspections
- Prepare and present progress and significant events for management review to senior division management with executive responsibility.
- Interact with and have ability to influence decisions of the various R&D and GPO Directors and Vice Presidents.
- Bachelor’s degree is required; typically in sciences, engineering or other technical/scientific areas
- 10 years+ of experience in Quality Assurance.
- Device regulation experience required.
- Very good people management skills