Vice President, Quality Assurance
Vice President, Quality Assurance
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Vice President Quality Assurance is responsible for the Quality Assurance function of Sirtex Medical Inc. and its subsidiary entities and serves as a leader for Sirtexs currently marketed products products in all stages of internal pipeline development and products that may be acquired by Sirtex from third parties. This role ensures that the quality management system is developed maintained and applied in a practical coordinated and effective manner for both medical device and pharmaceuticals in alignment with company requirements and objectives and in compliance with all applicable regulations and standards.
Reporting to the Senior Vice President Quality and Regulatory Affairs the Vice President Quality Assurance is responsible for the formulation implementation and realization of the Companys global Quality strategy. The Vice President Quality Assurance will: work with R&D Clinical Medical Regulatory Affairs and Engineering on the companys Quality strategy as a key input to product development; maximize on-time product approvals; manage strict regulatory practices globally within global standards of practice; maintain and protect the Companys existing product approvals; and develop and maintain high quality productive relationships with statutory regulatory bodies globally.
They will also serve as an expert related to the FD&C Act 21CFR 803 and 801 requirements. They will maintain ISO13485:2016-certified Quality Management System which is an integral part of achieving and maintaining required certifications and approvals and ensures consistent compliant operation of the company in line with our Value of Advancement: We have an unrelenting focus on quality. The Vice President Quality Assurance ensures that all of Sirtexs global Quality activities are undertaken in accordance with the highest ethical standards and in compliance with the laws regulations codes of conduct and other relevant guiding practices in the jurisdictions in which Sirtex and its subsidiary entities operate.
NOTE: This position will be considered a hybrid position at a minimum which is currently defined as 3 days/week in office and 2 days/week remote.
Primary Responsibilities:
- Lead the Quality Management System and Global QA team to ensure maintenance improvement and development of the QMS in accordance with company values policies requirements & objectives
- Lead all QA audit programs (internal/external)
- Foster a collaborative approach to key company initiatives that advance the mission of Sirtex
Qualifications :
- Minimum of a Bachelors degree Medicine Health Sciences Law Engineering or other relevant tertiary degree is required
- Further post-graduate degree in Regulatory Affairs e.g. Masters of Regulatory Science or post-graduate commercial degree e.g. MBA is desirable
- Minimum 10 years industry experience in a multi-national pharmaceutical AND medical technology environments is mandatory
- Demonstrated experience in obtaining FDA approval for IDE/PMA and IND/NDA/BLA therapies is mandatory
- Prior experience in leading successful CE submissions to EU Notified Bodies is desired
- Prior experience within a national regulatory agency US FDA EMA Australian TGA is desirable
- Extensive experience in people leadership and development
- Excellent communication presentation and influencing skills
- Willingness and ability to work within cross-functional teams of internal peers and mutli-disciplinary teams including external thought leader
- Travel approximately 15% with some international travel required
The target base salary range for this position will range from $241000 to $270000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors including your geographic location skills experience education and other factors as they relate to the position requirements. Actual compensation may vary depending on the confirmed job-related skills and experience.
In addition to the expected base compensation this role is eligible to participate in Sirtexs incentive programs (target bonus of 25% for this position) and benefit plans which include paid sick and vacation time health insurance and a generous 401k matching program.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Do you want to be part of something bigger A team whose impact stretches across the globe making a real difference to the quality of peoples lives. Sirtex recognizes that well-being financial health and work-life balance are crucial for our employees to achieve personal success.
Sirtex offers qualified candidates:
- Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
- A culture of respect diversity collaboration and innovation fostering inclusiveness and superior performance.
- Attractive compensation and benefit packages which are practical robust and equitable.
- A commitment to support ongoing professional growth through career development on the job experiences and training opportunities.
- Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
- An unwavering commitment to company values employee safety and excellence in everything we do.
Diversity drives innovation; inclusion fosters belonging growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement teamwork and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued included and can share their ideas so that we can exceed even our own expectations.
Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or veteran status age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
