Manager, QA Compliance - Supplier Audit
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POST DATE 8/12/2016
END DATE 11/3/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
With the commitment and drive you bring to the PDM workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
The Manager- QA Compliance, will report to the Associate Director of Distributor and Supplier Management. This key position will primarily perform audits of Gilead s contract testing laboratories with an emphasis on chemical component manufacture and testing as well as auditing of specialty laboratories and their associated analyses. The candidate will ensure consistent audit format, adherence to the audit life cycle metrics and completion of annual audits assigned.
Conduct vendor audits utilizing both questionnaires and on site audit assessments for GMP providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution in support of Gilead s clinical and commercial oral and parenteral dosage formulations and associated medical devices.
Manage all aspects of the audit lifecycle: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
Incorporate sound risk management principles for the establishment of the annual distributor/supplier audit schedule.
Work directly with operating entities to ensure completion of correct CA/PA to address compliance concerns identified during audits.
Participate in the development, implementation and maintenance of procedures and templates to assist the evaluation and distributor/supplier audits.
Identify compliance risks and escalate issues to appropriate levels of management for resolution.
Promote awareness across the commercial and clinical manufacturing platform of current regulatory agency requirements and trends
Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
Develop and maintain updates to annual distributor and Supplier Management global audit schedule
Develop and report trends based on internal external regulatory observations to better focus the scope of Distributor and Supplier Management audits
Drive consistency with audit report observation classification, status and overall risk
Assist in maintaining the accuracy of the approved Distributor and Supplier Management vendor electronic vendor management system.
Identify and drive audit program process improvements
Complete other auditing and related responsibilities as required.
Travel is required up to 50%
Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; and Health Canada R.S.C., 1985, F-27, Section 30; as well as ICH, ISO and USP / EP compendial standards and principals.
Skilled auditor with a minimum of five years experience and ability to perform investigative audits.
Detailed knowledge of the manufacturing and testing processes associated with APIs, Oral Solid Drug Product, Liquid Formulations, Biologics, Aseptic Fill / Finish, Primary and Secondary Packaging, and Clinical Kitting, and Warehousing / Distribution.
Practical understanding of current GMP and GDP concepts and industry practices.
Educational degrees related to Life Science.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Assigns, monitors and reviews progress and accuracy of work for an individual, a group of employees, or a project.
Follows up on questions from assigned departments.
Leads by example to foster a commitment to quality in personnel, and a culture of quality within the organization.
Assists with maintaining standard of quality for compliance department operations.
Assists in regulatory agency inspections.
Interacts and influences peers to ensure successful project completion.
Maintains current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility.
Provides guidance on interpretation and application of specified QA compliance regulations.
Assists in the evaluation and implementation of standard operating procedures and systems needed to comply with requirements.
KNOWLEDGE, EXPERIENCE AND SKILLS
Demonstrates excellent organization skills and ability to work on a number of projects to tight timelines.
Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance.
Demonstrates excellent verbal, written, and interpersonal skills.
Capable of taking a leadership role in updating and preparing the company for minor changes in regulation in.
8+ years of relevant experience in the pharmaceutical industry and a BS or BA.
6+ years of relevant experience and a MS
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 email@example.com for assistance.
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