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Cardiome Pharma Corp.
Director of Quality Assurance
Remote Locations Worldwide, BC V6T 1Z3 Canada
Head of Quality Systems
Cardiome is a pharmaceutical company based in Vancouver, B.C., Canada, with offices in Switzerland. Cardiome is seeking a globally experienced Director of Quality Assurance, based in the Vancouver head office. Reporting to the Head of Quality Assurance, the Director will be responsible for developing, implementing and executing global pharmaceutical GxP and promotional quality and compliance systems for Cardiome’s cardiovascular products to meet worldwide regulatory requirements. This position will manage quality systems to cover the entire lifecycle of product development and commercialization in line with business objectives and in collaboration with key stakeholders primarily outside, but including, North America. The Director will provide quality management leadership to a small internal team and oversight of contract service and material providers.
Key Responsibilities include but are not limited to
1. Hands-on development, implementation and execution of adaptive and compliant pharmaceutical quality management systems (QMS) strategies, policies and procedures to meet worldwide pharmaceutical quality systems requirements.
2. Execution, coordination and tracking of all QMS procedures and related activities including (but not limited to) internal audits, external audits, change management, document management, training management, batch review/release, annual product reviews, deviation investigations, complaints, recalls, regulatory inspection management, quality risk management and management review coordination.
3. Execution, participation and/or coordination of supplier approval and set-up processes, including conducting audits and reviewing quality agreements.
4. Assembly, monitoring and/or presentation of QMS metrics updates and status reports. .
5. Development and implementation of collaborative strategies to work as part of a multi-disciplinary team to ensure quality and compliant outcomes in a timely and cost effective manner.
6. Participation, preparation and implementation of global product quality and compliance strategies for development-stage programs and marketed products.
7. Anticipation, identification, prioritization and preemptive mitigation of quality risks through cost-effective compliance with all global regulatory requirements.
8. Work with cross-functional counterparts in Regulatory, CMC, Manufacturing, Supply Chain and Operations to achieve and maintain compliant and uninterrupted commercial supply.
9. Manage a small internal quality team.
10. Provide quality and compliance guidance and training on policies and procedures impacting commercial and development operations
Education, training, experience:
Qualifications and Skills Required:
• A minimum of a Bachelor’s degree in pharmacy, pharmaceutical sciences, chemical engineering, chemistry or a related life sciences discipline with at least 12 years of direct experience in the quality assurance/QMS aspects of both pharmaceutical product development and commercialization on a global basis, with at least 7 years in a department management role.
• Direct experience in the development of innovative quality assurance/QMS systems coupled with demonstrated track record of success in the delivery of cost-effective quality and compliant outcomes in fast-paced, dynamic organizational environments – including outsourced operating models.
• Broad knowledge and direct hands-on experience in all contemporary global GxP requirements (i.e., GMP/GLP/GCP/GDP/GVP).
• The successful candidate will have a demonstrated track record of successful interactions with and oversight of third party contractors and suppliers; international regulatory inspection preparation and hosting; and compliance with global quality requirements.
• The successful candidate will be able to provide innovative and knowledgeable GxP quality leadership on a cross-functional team and work effectively in a matrix environment through excellent influencing and interpersonal skills.
• Strong oral and excellent written communication skills are required, along with the ability to manage multiple tasks with competing priorities.
• This position will require up to 75% domestic and international travel coupled with the ability to effectively execute all responsibilities during travel periods. Availability and working during hours to accommodate other international time zones will be required at times.
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