Senior GMP Compliance Auditor
- Employer
- Kite Pharma
- Location
- Santa Monica, CA, United States
- Start date
- Oct 22, 2020
View more
- Discipline
- Administration, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
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Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Job Description
We are seeking a highly motivated individual to join us as a Sr. GMP Compliance Auditor in the Corporate Quality and Compliance department. In this role, you will participate in programs to improve GMP compliance and supportthe Senior Director along with site management in the preparation and management of audits.
Responsibilities (include but are not limited to):
Basic Qualifications:
OR
Preferred Qualifications:
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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.
For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead 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 log onto your Internal Career Site to apply for this job.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Job Description
We are seeking a highly motivated individual to join us as a Sr. GMP Compliance Auditor in the Corporate Quality and Compliance department. In this role, you will participate in programs to improve GMP compliance and supportthe Senior Director along with site management in the preparation and management of audits.
Responsibilities (include but are not limited to):
- Assist in the scheduling, performance, and tracking of Kite Audits in accordance with regulatory and company requirements.
- Lead several aspects of Internal and External audits: planning the audits, documentation, providing copies of requested documents, attending pre and post audit meetings, informing appropriate management, report generation and reviewing documentation of audit closure and follow-up for findings.
- Provide compliance expertise and support for the maintenance and continual development (or modification) of Kite's audit program; include and implement all applicable regulatory and company requirements.
- Responsible for review of audit reports prior to distribution.
- Prepare accurate and timely reports according to established procedures.
- Perform analyses of audit findings to identify any trends among noncompliance items.
- Maintain accurate records of audit findings and activities.
- Ensure that the audit program is up to date by tracking and reviewing Audit Master Schedule.
- Provide support for all quality-related issues.
- Provides training and competency.
- Create and sustain a culture that is based on continuous improvement.
- Execute audits to verify compliance with global Good Manufacturing Practices regulations, product CMC license/dossier filings, and corporate requirements.
- Assist with the planning and execution of External and Internal Audits.
- Support or act as lead auditor at manufacturing site internal audit(s).
- Assure tracking of key performance metrics and participate in periodic reviews to ensure suitability and effectiveness of the audit program.
- Assure communication of compliance concerns, regulatory agency expectations and industry trends as part of on-going education and training for GMP compliance.
- Work closely with Kite manufacturing sites in areas of GMP compliance.
- Act as internal compliance consultant and/or provide other resources with expertise.
- Support and assist other compliance team members with regulatory commitments, BPDRs, regulatory intelligence, MRB, inspection readiness activities and quality escalations.
- Identify opportunities for improvement, as well as identification and implementation of appropriate actions.
- Ability to travel up to 25%.
- Perform other duties as assigned.
Basic Qualifications:
- Bachelor's degree in life sciences or engineering discipline with 7 years of experience in regulated industry, biologics or biotech
OR
- Master's degree in life sciences or engineering discipline with 5 years of experience in regulated industry, biologics or biotech
Preferred Qualifications:
- 3+ years auditing experience in biologics, international experience
- American Society for Quality (ASQ), Certified Quality Auditor credentials
- Working knowledge of the regulatory environment for the manufacture of drugs, biologicals and cellular therapy products.
- Knowledge of blood/tissue components regulations a plus.
- Good understanding of global cGMP regulations and ISO standards.
- Strong analytical and demonstrated problem solving skills.
- Strong database management, including development, maintenance, and evaluation (metrics).
- Excellent verbal and written communication skills.
- Success working with multi-functional, global teams.
- Excellent interpersonal/communication/influencing/negotiation skills required.
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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.
For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead 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 log onto your Internal Career Site to apply for this job.
You need to sign in or create an account to save a job.
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