Director- QA Compliance
Director- QA Compliance
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$ 210375 - 272250
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
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 Gilead and help create possible together.
Job Description
The Director QA Compliance will report to the Executive Director of Supplier Management and Auditing. This key position will be the acting Global Process Owner for External Audits and conduct GMP audits of Gileads global suppliers with a primary focus on external biologics manufacturing contract packaging and contract testing labs. This position will lead audits to support the effectiveness of the global audit program and will work closely with cross functional partners and internal stakeholders.
Lead the development implementation and maintenance of procedures and templates to assist in the evaluation of and in improvement of the auditing process.
Develop strategy for cross training and maintenance of auditor and SME qualifications
Assist in overall scheduling and productivity/capacity modeling for audit team
Identify compliance risks and escalate issues to appropriate levels of management for resolution.
Promote awareness across the biologics commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the trends identified to better focus the scope of audits.
Align strategize and collaborate with the Global Supplier Quality function within Gilead
Enhance Global Third party Quality Oversight program and Qualification Process by leading initiatives to maintain compliance to global regulations and standards
Represent the Quality function in by developing the program and supporting the selection process for new/preferred suppliers
Act as liaison between global supplier quality and Gileads production facilities
Conduct global vendor audits for contract manufacturing of Gilead Biologics
Support and/or conduct audits of providers of raw materials product contact consumables contract manufacturing or testing software warehouse / distribution in support of Gileads clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned.
Manage all aspects of the audit lifecycle including scheduling planning issuing agendas executing issuing reports evaluating responses requesting clarification issuing CA/PA and closing.
Drive consistency with audit report observation writing classification status and overall risk
Conduct due diligence assessments as part of global expansion as required
Identify and drive biologics audit program improvementsand meet all required metrics and assigned goals
Ensure CA/PA to address compliance concerns identified during audits are commensurate with current biologics industry practices and benchmarks
Ensure that the audit agenda is riskbased and has the appropriate internal and/or external subject matter experts as part of the audit team.
Work directly with Gilead crossfunctional departments to gather key information and feedback prior to conducting vendor auditsin order to ensure effectiveness.
Travel is required up to 50
This will be an onsite role and can be located in Foster City CA OR Parsippany NJ
Essential Functions:
Supports Compliance management in maintaining the companys Compliance program.
Manages the daytoday activities of one or more individual contributors including task assignment and prioritization monitoring task performance and conducting performance reviews.
Ensures awareness of biologics compliance requirements across impacted functional areas
Establishes excellent working relationships with compliance/quality groups.
Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars and individual selfstudy including periodic review of all relevant regulations guidance documents and requirements.
Responsible for providing guidance on interpretation and application of existing and new requirements. Provide guidance to assigned departments and management when specific compliance issues arise.
Assists in evaluation and implementation of standard operating procedures and systems needed to comply with requirements.
Leads various types of audits or projects or supervises contractors. Audits may include internal systems audits external vendor audits or document reviews.
Assists in regulatory agency inspections. Assists in coordination of responses to any regulatory agency findings.
Basic Qualifications:
10 years of relevant experience in the pharmaceutical industry and a BS or BA in a relevant field of study.
8 years of relevant experience and a MS in a relevant field of study.
Extensive background in Biologics Operations (e.g. Manufacturing Quality Control Quality Assurance)
Demonstrates excellent verbal written and interpersonal skills.
Demonstrates a thorough knowledge of compliance requirements and an understanding of current global and regional trends in compliance.
Knowledge of domestic and international regulations including 21 CFR Parts.; EudraLex Volume 4 and applicable annexes; and Health Canada R.S.C. 1985 F27 Section 30; as well as ICH ISO PIC/S and USP/NF EP and JP compendial standards and principals as applicable.
Skilled auditor with 10 years of experience and ability to perform investigative audits
Is capable of taking a leadership role in updating and preparing the company for changes in regulations.
Is capable of leading a small team in development of systems and procedures and implementation.
Is well recognized as a knowledgeable resource for QA compliance advice in other departments.
Capable of effectively managing a small team of experienced subject matter experts in of audits.
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights 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 Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Director
Employment Type
Full-Time
