Senior Manager, RA Quality and Compliance Excellence

Welcome to Gilead Sciences, a leading biopharmaceutical company dedicated to advancing the treatment of life-threatening diseases. We are seeking a highly skilled and experienced Senior Manager, RA Quality and Compliance Excellence to join our team.As a Senior Manager in our Regulatory Affairs (RA) department, you will play a critical role in ensuring the quality and compliance of our products throughout their entire lifecycle. You will have the opportunity to lead a team of talented professionals and collaborate with cross-functional teams to drive continuous improvement and excellence in our regulatory processes.To excel in this role, we are seeking an individual with a strong background in regulatory affairs and quality compliance, as well as a proven track record of leadership and project management. If you are passionate about making a difference in the lives of patients and thrive in a dynamic and fast-paced environment, we invite you to apply for this exciting opportunity.

1. Oversee and manage all aspects of regulatory affairs and quality compliance for our life-saving products.
2. Lead and develop a team of professionals to ensure efficient and effective execution of regulatory processes.
3. Collaborate with cross-functional teams to drive continuous improvement and excellence in regulatory processes.
4. Develop and maintain strong relationships with regulatory authorities and ensure compliance with all applicable regulations and guidelines.
5. Develop and implement strategies to obtain and maintain regulatory approvals for new and existing products.
6. Ensure timely and accurate submission of regulatory documents and reports.
7. Monitor and assess emerging regulatory trends and changes to ensure company compliance.
8. Conduct regular audits and inspections to ensure compliance with internal policies and external regulations.
9. Communicate and provide guidance to internal stakeholders on regulatory requirements and changes.
10. Develop and maintain standard operating procedures and policies to ensure compliance with regulatory requirements.
11. Manage and track all regulatory submissions and approvals to ensure timely and successful completion.
12. Provide leadership and mentorship to team members, promoting a culture of continuous learning and development.
13. Represent the company in regulatory meetings and negotiations.
14. Develop and maintain strong relationships with key stakeholders and partners.
15. Monitor and report on key performance indicators related to regulatory compliance.
16. Stay up-to-date with industry trends and best practices in regulatory affairs and quality compliance.
17. Ensure that all processes and procedures are aligned with company values and objectives.
18. Maintain a high level of professionalism and integrity in all interactions and communications.
19. Act as a subject matter expert and resource for all regulatory affairs and quality compliance matters.
20. Continuously evaluate and improve processes to drive efficiency and effectiveness in regulatory processes.

According to JobzMall, the average salary range for a Senior Manager, RA Quality and Compliance Excellence in Parsippany-Troy Hills, NJ, USA is $120,000 to $155,000 per year. The exact salary will vary depending on factors such as the individual's level of experience, education, and specific job responsibilities within the role. Additional factors such as the company's size, industry, and location may also impact the salary range.

Gilead Sciences, Inc., is an American biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.