Senior GMP Compliance Auditor

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: September 17, 2020

Job Description:

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: Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.

We are seeking a highly motivated individual to join us as a Sr. GMP Compliance Auditor in the Corporate Quality and Compliance department. This individual will participate in programs to improve GMP compliance and support the Senior Director along with site management in the preparation and management of audits.

Responsibilities (include but are not limited to):

Assists in the scheduling, performance, and tracking of Kite Audits in accordance with regulatory and company requirements.

Leads 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.

Prepares accurate and timely reports according to established procedures.

Performs analyses of audit findings to identify any trends among noncompliance items.

Maintains 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 as needed.

Create and sustain a culture that is based on continuous improvement.

Other compliance support duties as assigned.

Executes 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), as requested.

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 as needed 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.

Requirements:

Bachelor's degree in life sciences or engineering discipline and 7 years of experience in regulated industry, biologics or biotech.

Minimum of 3+ years auditing experience in biologics, international experience preferred

American Society for Quality (ASQ), Certified Quality Auditor credentials preferred

Working knowledge of the regulatory environment for the manufacture of drugs, biologicals and cellular therapy products.

Knowledge of blood/tissue components regulations a plus.

Must understand 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 multifunctional, global teams.

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 contact  careers@gilead.com  for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’  poster.

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: Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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Keywords: Gilead Sciences, Inc., Santa Monica , Senior GMP Compliance Auditor, Other , Santa Monica, California