TrackWise Business Lead Manager
Specific Responsibilities
With the commitment and drive you bring to the PDM workplace, 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 PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Responsibilities
This individual will perform the role of Business Lead and Business Process Owner for the TrackWise application.
Coordinate business needs effectively across the key stakeholders of each TrackWise workflow (e.g. CAPA, Change Management, Deviation, Audit, etc.).
Manage a small team to perform daily business administrative tasks related to functional support (Level 2/3 Support) and general user account administration of the TrackWise application and Quality Enterprise Systems.
Own and administer a train-the-trainer program for TrackWise business administrators.
Ensure proper end user training on TrackWise is available and updated as needed.
Drive the analysis, development, testing, and deployment of configuration, workflow, reporting and/or software updates to improve the overall accuracy, efficiency, and effectiveness of the system.
Effectively identify and resolve system issues and appropriately communicate to management, business leads and users as needed.
Conduct impact assessment of GXP computer system-related deviations and change controls.
Work on problems of greater complexity in scope where analysis of situations or data requires in-depth evaluation of various factors; good judgment is required in resolving problems and making routine recommendations.
Exercise judgment within approved policies and procedures in selecting methods, techniques and evaluation criteria for obtaining results.
Support and maintain corporate system processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
Support the development and management of quality metrics to optimize performance, productivity, effective resource planning, and management review.
Participate in cross-functional project teams.
Essential Duties And Job Functions
Implements business applications determined by immediate manager in specialized functional area.
Applies implementation methodology and recommends resources required to deliver the application to a specific area of the business.
May coordinate and/or direct the work activities of staff or other team members on project-oriented tasks.
Assesses and analyzes business requirements and recommends solution and plan. If supporting a regulated function, understands and performs validation efforts in accordance with legal requirements (e.g. GxP).
Manages the team to ensure they meet the full requirements of their role. Conducts professional appraisals for team members and effectively manages performance.
The Manager will be able to apply their expertise to make a major contribution to a specific business unit or department.
Knowledge, Experience And Skills
Experience in the Life Sciences industry. Knowledge of GMP regulations and procedures to maintain regulatory compliance. Familiarity with Quality processes such as Change Management, CAPA, Deviation, Audit, etc.
Prior experience implementing and/or managing Quality Management Systems.
Experience with validated computer systems, managing data integrity and configuration changes.
Supervisory Relationships: Often heads a centralized functional activity. Empowers others to take and make decisions and supports them as necessary.
Management Responsibilities and Policy Involvement: May provide direction to subordinates based on general policies and management guidance. Work is reviewed upon completion for adequacy in meeting objectives. Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies.
8+ Years with BS, BA and or relevant experience
6+ Years with MS, MBA
2+ Years with PhD
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
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.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without regard to race, color, religion, national origin, gender, age, sexual orientation, 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
For more information about equal employment opportunity protections, please view the
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.
