Sr. Manager, QA Compliance Global Quality Agreement Program

Sr. Manager, QA Compliance Global Quality Agreement Program
United States - Remote

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. Gilead’s 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 company’s five core values. That’s 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/

Specific Responsibilities:
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.

Responsible for managing the entire QAG life-cycle process (processing requests, reviewing, drafting, negotiating, routing for approvals/signatures, archiving, amending/revising, conducting periodic reviews, and retiring) for QAGs with Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), GMP Materials Suppliers, GMP Services Providers, Strategic Clinical Collaboration Partners, Commercial Marketing Partners, as well as for 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
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

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
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

Other duties as required or assigned by Director to meet business needs

*Strong preference for candidate to be in Foster City location (Relocation Assistance is available) however will consider Remote candidates

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 OR 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.

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' 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 log onto your Internal Career Site to apply for this job.




jeid-18430052bb95a04fbaa75533d3b2bdea