Associate Director, QA Compliance Audits
Associate Director, QA Compliance Audits
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing 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 Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Role and Responsibilities:
As the Associate Director, QA Compliance you will play a vital role in conducting GMP audits of Gilead's global suppliers such as contract manufacturing, contract packaging and labeling, and contract testing labs. You will lead audit teams to support the effectiveness of the global audit program with a focus on large molecule biologics (Oncology). You and your team will work closely with each of the GMP/GDP various functions and stakeholders at the Alberta, Cork, Foster City, Oceanside, San Dimas/LV, and New Jersey sites. This position reports to the Director of Quality Assurance Compliance. Important responsibilities include:
- Conduct global vendor audits for Gilead GMP providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution, including biologic and aseptically manufactured drug substances and drug products in support of Gilead's clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned.
- Capable of auditing using various formats such as On-site, Virtual, or by Questionnaire
- Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, managing an audit team, requesting clarification, issuing CA/PA, and closing.
- Maintain individual metrics and key performance indicators at required levels.
- Execute individual assigned audits in alignment with established expectations.
- 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.
- Work directly with Gilead cross-functional departments to gather key information and feedback prior to conducting vendor audits to ensure robustness and effectiveness.
- Ensure completion of correct CA/PA to address compliance concerns identified during audits as applicable.
- Participate in the development, implementation, and maintenance of procedures, tools and templates to assist in the evaluation of suppliers and to assist in improvement of the auditing process.
- 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 and develop and report on the trends identified to better focus the scope of audits.
- Drive consistency with audit report observation wiring, classification, status, and overall risk
- Ensure all supplier information is accurate in support of the Approved Supplier List
- Conduct due diligence assessments as part of global expansion as required
- Identify and drive program improvements and meet all assigned goals
- Other responsibilities as required.
Domestic and International travel is required up to 50%
- Supports Compliance management in maintaining the company's Compliance program.
- May manage the day-to-day activities of one or more individual contributors, including task assignment and prioritization, monitoring task performance, and conducting performance reviews.
- Ensures awareness of compliance requirements and responsibilities within the function.
- 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 self-study 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.
- May lead various types of audits or projects or supervise 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.
Knowledge, Experience & Skills:
- Demonstrates excellent verbal, written, and interpersonal skills.
- Demonstrates expertise in auditing of Biologic drug substance and drug product manufacturers
- Demonstrates a thorough knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.
- 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, procedures and their 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 execution of audits.
- 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 filed of study.
- Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. 210, 211, 600, 610, and 820; EudraLex Volume 4 and applicable annexes; Health Canada GMPs, ICH, ISO, PIC/S, USP/NF, EP, and JP compendial standards and principles as applicable.
- Japanese GMPs
- Skilled auditor with 10 years of experience and the ability to independently perform investigative audits.
- Experience in Auditing of Aseptic Manufacturing suppliers, Large Molecule Biologics
- ASQ, ISO, or other Auditing certification
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 commercializes 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.
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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