Sr Labeling Project Coordinator
gilead · United States - California - Santa Monica ·
- Seniority
- Senior
- Category
- Project management
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
Key Responsibilities:
- Serve as a labeling subject matter expert and provide guidance across Regulatory Affairs, Legal, Package Engineering, Quality Assurance.
- Label Template Review and Approval review and approve label design templates
- Lead and support complex labeling projects where established precedents may not exist, requiring independent judgment and innovative problem-solving.
- Manage cross-functional labeling implementation activities to ensure product labeling changes are executed accurately and within required timelines.
- Coordinate the implementation of new labeling with Materials Management and multiple manufacturing or packaging sites.
- Drive the completion of complex labeling processes by collaborating with stakeholders and ensuring compliance with regulatory and business requirements.
- Develop and recommend process improvements based on novel approaches to existing labeling operations and workflows.
- Author, revise, and improve systems, procedures, and SOPs to enhance labeling efficiencies, compliance, and operational effectiveness.
- Ensure labeling activities comply with FDA regulations, cGMP requirements, and applicable regulatory guidance documents.
- Facilitate communication and alignment among cross-functional teams to resolve labeling issues and support successful implementation.
- Support continuous improvement initiatives focused on labeling accuracy, compliance, consistency, and operational excellence.
Basic Qualifications:
- At least 5 years of relevant experience with a BS/BA degree,
OR
- At least 4 years of relevant experience with an MS degree.
- Pharmaceutical industry experience required.
- Strong knowledge of FDA regulations, cGMP requirements, and regulatory guidance documents.
- Demonstrated expertise in product labeling operations and labeling implementation processes.
- Strong verbal communication, technical writing, and interpersonal skills.
- Experience managing complex cross-functional projects and stakeholder relationships.
- Proficiency with Microsoft Office applications.
- Ability to develop process improvements, drive operational changes, and work effectively in ambiguous or evolving environments.
Preferred Qualifications:
- Labeling experience preferred
Onsite Requirement:
3x days per week
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .
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For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.