Gilead Sciences, Inc. Sr. Manager, QA Compliance - Global Quality Agreements in Foster City, California

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

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/

Specific Responsibilities:

The Senior Manager, QA Compliance will report to the Director, QA Compliance – Global Quality Agreements within the Supplier Management and Audits department. This is a newly created position dedicated to support the establishment, implementation and maintenance of the Gilead Global Quality Agreement Program initiatives. This position will have high visibility and will collaborate with essential key internal partners/stakeholders to ascertain Quality/business requirements to establish effective and timely Quality Agreements with various types of GMP suppliers/service providers, customers and strategic alliance/marketing partners.

  • Responsible for assisting with the implementation of the Global Quality Agreement Program initiatives (governance, oversight, processes and services) by collaborating cross-functionally and geographically with key stakeholders

  • Responsible for managing the Quality (Technical) Agreement (QAG) life-cycle process (processing requests, reviewing, drafting, negotiating, routing for approvals/signatures, archiving, amending/revising, conducting periodic reviews, and retiring) for Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), GMP Materials Suppliers, GMP Services Providers, as well as Marketing/Strategic Alliance Partners and Intra-Company GMP activities, in accordance with applicable GMP regulations and Gilead policies, procedures and practices. Perform risk assessment of proposed terms/quality provisions in QAGs and develop recommendations to minimize their potential risk to the business

  • Co-develop negotiation strategies with and ensure the completion of applicable reviews of QAGs by key stakeholders (Quality (Clinical/Commercial) personnel, 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

  • Coordinates meetings with external parties (CMOs, CTLs, GMP Material Suppliers, GMP Services Providers) and internal stakeholders/SMEs and facilitates the review and negotiation of QAGs

  • Coordinate 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

  • Assists with the administration and maintenance of the Global QAG database/tracker to reflect real time data/status; assists with the generation and preparation of QAG/Program metrics / status reports and presentations to Senior Leadership

  • Responds to requests and inquiries related to QAGs (content/statuses, etc.) from internal stakeholders

  • Assist in the development and implementation of policies, standards, SOPs, work instruction/job aids for the management of QAGs and compliance monitoring thereof

  • Creates training materials and conducts training related to QAGs ,the Global QAG Program and its systems and tools

  • Collaborates with key stakeholders to develop standardized, fit-for-purpose QAG Templates; Manages the review, approval, issuance, revision and retirement of QAG Templates

  • Provides global QAG Program systems and processes support to SMA/QAG team and participates in system and process improvements and remediation (perform gap assessments and participate in development and execution of remediation strategies

  • Other duties as required or assigned by Manager to meet business needs

Essential 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 & Skills:

Essential:

  • 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 regulations.

Specific Education & Experience Requirements:

8+ years of relevant experience in the pharmaceutical industry and a BS or BA.

6+ years of relevant experience and a MS

Desirable:

  • Demonstrates expertise with quality agreements for both domestic and international GMP regulations and/or extensive contracting (contract drafting/negotiating) experience in the pharmaceutical/biopharmaceutical industry

  • Demonstrates excellent influencing, negotiation, and technical / business writing skills

  • Excellent project management skills / experience

  • Demonstrates the ability to incorporate sound Risk Management fundamentals in the establishment of quality agreement content

  • Demonstrates excellent technical/business/legal writing skills; must have strong document or contract management skills (word processing/formatting)

  • Excellent working knowledge of computer systems/applications; i.e. Microsoft Word, Excel, Pivot tables, Visio, Gantt Charts, and PowerPoint

  • In-depth experience with electronic document control management or electronic contract life-cycle management systems (e.g.: Documentum, Veeva Quality Docs, Apttus, Ariba, or other electronic document control/contract life-cycle management systems)

  • Strategic and technical knowledge for managing global quality agreement processes for various types of service providers

  • Supplier management or audit management experience

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

About 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.

#LI-MT1

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’ at http://www.eeoc.gov/employers/upload/posterscreenreader_optimized.pdf poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT at http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT at http://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

PAY TRANSPARENCY NONDISCRIMINATION PROVISION at https://www.dol.gov/ofccp/pdf/PayTransparencyNotice_JRFQA508c.pdf

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 log onto your Internal Career Site to apply for this job.

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.

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 at http://gilead.avature.net/Gilead