Quality Compliance Manager, Safety & Medical Quality

Amgen is seeking a highly motivated and experienced Quality Compliance Manager to join our team and ensure the highest standards of safety and medical quality across our organization. As the Quality Compliance Manager, you will play a crucial role in maintaining our reputation as a leader in the biotech industry. We are looking for someone who is passionate about compliance, detail-oriented, and has a strong background in safety and medical quality. If you are a driven individual with a strong understanding of FDA regulations and a proven track record of implementing and maintaining compliance programs, we want to hear from you. Join us in our mission to deliver life-changing medicines to patients around the world.

1. Develop and maintain a comprehensive understanding of FDA regulations, industry standards, and company policies related to safety and medical quality.
2. Oversee the implementation and maintenance of a robust compliance program to ensure adherence to all applicable regulations and standards.
3. Conduct regular audits and inspections to identify potential compliance issues and develop effective corrective and preventive action plans.
4. Collaborate with cross-functional teams to ensure that quality and safety standards are incorporated into all aspects of the organization's operations.
5. Monitor and report on key performance indicators to track compliance and identify areas for improvement.
6. Provide guidance and support to all departments on compliance-related matters, including training and education to promote a culture of compliance throughout the organization.
7. Stay updated on industry trends and changes in regulations to proactively identify potential risks and recommend appropriate actions.
8. Act as the primary point of contact for regulatory agencies and ensure timely and accurate responses to inquiries and requests.
9. Lead and participate in internal and external audits and inspections, and ensure timely resolution of any findings.
10. Drive continuous improvement initiatives to enhance the organization's compliance program and processes.
11. Collaborate with stakeholders to develop and implement risk management strategies to mitigate compliance risks.
12. Maintain accurate and up-to-date documentation of all compliance-related activities.
13. Train and mentor team members to ensure a high level of compliance awareness and knowledge across the organization.
14. Represent the organization in compliance-related meetings, conferences, and industry events.
15. Act as a subject matter expert and provide guidance and support to other departments on quality and compliance matters.

According to JobzMall, the average salary range for a Quality Compliance Manager, Safety & Medical Quality in Thousand Oaks, CA, USA is approximately $84,000 to $120,000 per year. However, this can vary depending on factors such as years of experience, industry, and company size. Some companies may also offer additional benefits and bonuses.

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.