Manager, R&D Info Systems
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.
Specific Responsibilities and skills for the position:
- Serve as the System Matter Expert/Business Admin/ Business Liaison for the following PDM supported systems:
* Other systems appointment by management.
- Managing compliance and maintaining standards for validation, administration, change management, support and project management for the above systems.
- Support the Pharmaceutical Development & Manufacturing (PDM) quality processes and its continuous improvement with regards to system management.
- Collaborate with Business units, Quality Assurance, IT and Regulatory Compliance groups at Gilead to support PDM methodology to implement computer systems in an efficient manner.
- Completing project activities in accordance with requirements, master plans, procedures and protocols.
- Providing training to end users for process control system.
- Provide vendor management and coordination of vendor support.
- Presenting validation packages to regulatory authorities during routine and pre-approval inspections.
- Providing support for systems used in development, manufacturing, quality control and quality assurance.
- Manage timely and successful completion of systems project, preventative maintenance and enhancement releases. In this position he/she is responsible for developing and tracking against project schedules as well as the completion of the validation effort within the project schedule while working with cross functional team members.
ESSENTIAL DUTIES AND JOB FUNCTIONS
- Provides support on all phases of the System Development Lifecycle (SDLC) during the implementation of PDM supported computer systems in accordance with global regulatory requirements and Gilead procedures.
- Supports validation activities and risk assessments to ensure that the PDM systems are maintained in a state of control. Candidate works with members from the validation team, business unit, Quality Assurance, PMO and IT to execute a risk-based systems implementation approach and manages the issue management process.
- Responsible for developing, supporting and managing the portfolio of computer systems, such as Maximo, LabWatch and commercial manufacturing in the PDM organization.
- Responsible for managing budgets, LE and forecasting of expenditures.
- This role will require strong Computer Systems Validation / Business Analyst / Project Management skills along with leadership & communication skills.
KNOWLEDGE, EXPERIENCE AND SKILLS
8+ Years with BS, BA and or relevant experience
6+ Years with MS, MBA
2+ Years with PhD
- 5 years of experience supporting Maximo or other EAM system
- Experience in pharmaceutical processes including systems lifecycle processes, change control, authoring and executing computer systems validation and issue management deliverables.
- Experience with validation lifecycle methodologies and SDLC best practices.
- Proficient in current Good Manufacturing Practices (cGMPs), Part 11 and Annex 11 requirements.
- Experienced in developing validation and data migration methodology for global implementation of systems.
- Experience with supporting systems such as Maximo (prefer) or other Enterprise Assess Management (EAM) system.
- Experience in managing multiple projects, developing and managing project schedules. PMP certification is a plus.
- Exceptional interpersonal skills, including teamwork, coordination, facilitation, and negotiation.
- Strong leadership and project management skills.
- Excellent analytical, problem-solving and technical skills.
- Detailed oriented, systematic and rapid learner.
- Excellent planning and organizational skills.
- Exceptional written and verbal communication skills.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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, view the EEO is the Law poster at :