Manager, Quality Assurance
Wednesday, November 2nd, 2011Vancouver, BC
SPECIFIC ACCOUNTABILITIES
- As a QA inspector, monitors GLP studies to assure Test Facility Management/Test Site Management (TFM/TSM) that the facilities, equipment, personnel, methods, practices, records and controls in conformance with GLP regulations. Performs the planning and conducting of audits and inspections in support of in-house bioanalytical testing to ensure compliance with worldwide health authority regulations and guidelines, site SOPs, protocols, and industry standards, as applicable. Oversees and manages GLP inspections and mentors other QLT GLP inspectors.
- Manages the GLP archives including overseeing Archive staff.
- Coordinates and directs the work of other QA team members involved in GLP inspections and/or archiving including training, coaching and developing skills.
- Develops and optimizes GLP Quality policies and SOPs.
- Conducts in-house GLP training.
- Maintains professional expertise and knowledge of all applicable regulations.
- May also conduct GMP inspections for facilities and related equipment or participate in other Quality Assurance work.
- Collaborates and interacts with others in a mutually supportive and cooperative manner that reinforces the concept that staff at all levels is expected to seek ways in which they can support and assist others to achieve expected results, as well as to be affective in their own accountability areas.
REQUIREMENTS
- BSc in Chemistry, Chemical Sciences, Biochemistry or equivalent education.
- A minimum of 6 years of Quality systems experience including 4 years in a GLP QA management role with responsibility for overall GLP quality operations. Experience managing GLP inspections conducted by regulatory authorities. Direct interaction experience with regulatory GLP inspectors. In-house pharmaceutical company experience preferred.
- QA experience with other quality systems including clinical and commercial pharmaceutical GMP and/or medical device QSR will be an asset.
- Advanced understanding of the application of OECD and FDA Principles of GLP.
- Ability to interact effectively with all levels of personnel within the Company and externally with CROs and regulatory inspectors.
- Proven ability to establish new quality systems and optimize existing systems, review documentation, processes and procedures, identify issues, assess compliance, communicate findings clearly and succinctly and work with internal and/or external stakeholders to resolve these issues effectively.
- Demonstrated initiative and ability to be highly productive with minimal supervision.
- Excellent English verbal and written communication skills.
- Proven leadership abilities including the ability to motivate, coach and develop employees.
- Interest and willingness to cross-train in other Quality Assurance areas.