Sr. Manager, QA Compliance Global Quality Agreement Program
Sr. Manager, QA Compliance Global Quality Agreement Program
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
Sr Manager, QA Compliance - Global Quality Agreement Program
Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team 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 QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/
The Sr. Manager, QA Compliance will report to the Director, QA Compliance - Global Quality Agreement Program within the Global Quality Systems & Compliance (GQSC) department. This position is dedicated to support the Gilead Global Quality Agreement Program. This position will have high visibility and will collaborate with key internal partners/stakeholders to establish and maintain effective and timely Quality (Technical) Agreements (QAGs) with various GMP-related relationship types and support program related initiatives.
o Develops negotiation strategies with and ensure the completion of applicable reviews of QAGs by key stakeholders (Gilead personnel from Quality (Clinical/Commercial), Production/Operations, Outsourcing Management, Supply Chain Management, Business Operations Contract Compliance (BOCC), Alliance Management, Legal/Contracts and/or other applicable Subject Matter Experts), obtaining leadership approvals, as required, to ensure Gilead position is operationally correct and accurately reflected in the QAG. Ensures the QAG is in alignment and not conflicting with the primary, business agreement
o Coordinates meetings with external parties (e.g.: CMOs, CTLs, GMP Material Suppliers, GMP Services Providers) and internal stakeholders/SMEs and facilitates the review and negotiation of QAGs
o Coordinates systems and procedures related to processing of QAGs; prepares/assembles the final QAG package for authorized approval signatures and publishing in global electronic QAG life-cycle management system / repository
o Assists with the administration and maintenance of the Global QAG database/trackers to reflect real time data/status; assists with the generation and preparation of QAG/Program metrics / status reports and presentations to Senior Leadership
o Responds to requests and inquiries related to QAGs (content/statuses, etc.) from internal stakeholders
o Assists in the development and implementation of policies, standards, SOPs, work instruction/job aids for the management of QAGs and compliance monitoring thereof
o Creates training materials and conducts training related to QAGs, the Global QAG Program and its systems and tools
o Collaborates with key stakeholders to develop standardized, fit-for-purpose QAG Templates; Manages the review, approval, issuance, revision and retirement of QAG Templates
o Provides global QAG Program systems and processes support to GQSC QAG team and participates in system and process improvements and remediation (perform gap assessments and participate in development and execution of remediation strategies
*Strong preference for candidate to be in Foster City location (Relocation Assistance is available) however will consider Remote candidates
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 & Skills:
Specific Education & Experience Requirements:
8+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 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.
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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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