For Current Gilead Employees and Contractors:
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Sr. Manager, Supply Chain Information Systems
This position within the Pharmaceutical Development & Manufacturing (“PDM”) organization is responsible for the systems, data, and processes supporting the assembly and management of product details used to drive the supply chain. This involves taking specific product registration and filing information such as the approved drug substances, sites of manufacture, and packaging sites for a given drug product, country and market, creating a ‘docket’ by entering it in a structured and organized way into a product information management system, and them making this data available to support the release of product to authorized markets.
This position is also responsible for driving alignment, standardization and harmonization of product detail processes and in how this information is queried, reported, analyzed, and visualized to support the supply chain and quality assurance groups, such as in being able to check whether a particular lot can go to a specific market. In addition, ensuring product detail information is kept current and up-to-date to reflect the most recent changes and amendments to filings is critical. Finally, this position is responsible for measuring the effectiveness, data quality, and use of product detail management system.
- Responsible for managing the product information management system as a business process architect, leading a team of project managers, business analysts, developers, validation specialists, testers, and technical writers in systems implementation, enhancements, and operations.
- As a subject matter expert in managing the relevant product information data derived directly from regulatory filing and product registration processes, be responsible for the development of multi-year capability and technology roadmap to advance maturity level across key areas of regulatory information management including registration, submission, publishing, authoring, archiving, and product detail management.
- Assist in the process of submission of regulatory publication to health authorities and track approval status, timing, and the corresponding process to update product information management system, for both new submissions and updates.
- Analyze product registration processes and impacted datasets to define process and data improvements for efficiency, compliance, and effectiveness checking
- Analyze operational and system procedures of managing product information data to make recommendations and implement action plans for future improvement.
- Develop and operationalize SOPs, Work Instructions, KPIs/metrics for managing product information.
- Perform effectiveness checks the data quality, accuracy, management of the product information management system
- Perform direct end-user engagement to observe how users use the product information management, understanding where there are improvement opportunities and successes
- Develop and deliver end user training materials, conduct training in support of ongoing operations.
- Expertise and familiarity of software development lifecycle (SDLC) methodologies in a regulated environment, and implements business applications following methodologies
- Experience in 21 CFR Part 11 compliance, 21 CFR Part 210, 211, 820, 58, eCTDs, regulatory filings and submission processes and formats
- Knowledge of data integrity and attributes of good data quality such as ALCOA+
- 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 regulatory 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.
- May provide direction to team members based on general policies and management guidance in RA-CMC, Quality Assurance Groups.
- Interprets and executes policies and procedures that affect regulatory information management systems
- Recommends modifications to operating policies, procedures, standards and work instructions.
Knowledge, Experience & Skills:
- A Bachelor's Degree with a minimum of eight (8) years of relevant experience.
- A Master's Degree or MBA with a minimum of six (6) years of relevant experience.
- A PhD with a minimum of two (2) years of relevant experience.
- Experience in pharmaceutical processes including Supply Chain Management, 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.
Preferred knowledge Experience & Skills
- Demonstrates working knowledge of Supply Chain and Quality Systems and GMP requirements.
- Experience of entire validation system lifecycle
- Ability to work in a fast paced environment
- Experience in managing multiple projects, developing and managing project schedules.
- Exceptional interpersonal skills, including teamwork, coordination, facilitation, and negotiation.
- Strong leadership, communication and presentation 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.
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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For Current Gilead Employees and
Please log onto your Internal Career Site to apply for this job.