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Manager, Product Lifecycle Management

Manager, Product Lifecycle Management
Working at Gilead
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (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.
Specific Responsibilities:
This is a PDM position that helps drive alignment, standardization and harmonization of Product Lifecycle Management processes and the underlying data across the entire Supplier network. It is critical to deploy Supply Chain systems that are flexible enough to accommodate the underlying complexities of our Clinical and Commercial Supply Chain. And at the same time, the systems should enable PDM users to measure effectiveness of our PLM operational processes and introduce the desired level of improvements, where necessary.
  • As a manager of PLM Process Stewards, refine and deliver Commercial and Clinical Supply Chain Roadmap to advance maturity level across key Plan – Source – Make – Deliver areas
  • Analyze PLM data quality, completeness and on-time availability to key dataset for faster decision making and improved analytics
  • Analyze regulatory filing and product registration process, impacting lot-level eligibility, jurisdiction control and Supply Chain planning, at the level of of Bulk,Britestocks and FGs
  • Analyze and evolve success criteria defined for PLM Operations stabilization and make recommendations for future improvement.
  • Help define key performance indicators, metrics and criteria to measure and assess Product information quality within the PLM ecosystem
  • Develop and operationalize SOPs and Work Instructions for future enhancements in PLM, conduct periodic reviews, publish Data Reconciliation Reports with quality metrics towards Data Integrity 
  • Perform effectivity check for the Operational procedures for Supply Chain Systems e.g. SAP, EBS, Kinaxis RR, GPLM, GPID etc. to ensure process and data integrity
  • Maintain inventory of Operational challenges and prepare contents for the Operational Working Groups in PLM
  • You will be involved in transformational initiatives e.g. Project BlueStream, RIM, GPLM Operations etc. to deliver future use cases and business processes to advance the roadmap and maturity of business process governance/stewardship
  • Develop and deliver end user training materials, conduct training in support of ongoing PLM operations
Essential Functions:
  • Implements business applications determined by immediate manager in Clinical and Commercial Supply Chain functional areas.
  • Applies implementation methodology and recommends resources required to deliver the application supporting AO, Global Supply Chain, CMOs and Gilead’s site Supply Chain.
  • May coordinate and/or direct the work activities of staff or other team members on project-oriented tasks, including but not limited to GPLM, RIM, SAP, Serialization etc.
  • 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.
  • The Manager will be able to apply their expertise to make a major contribution to Commercial Manufacturing and Pharmaceutical, and Biologics Operations (PBO) function.
  • May provide direction to team members based on general policies and management guidance in Supply Chain.
  • Interprets and executes policies and procedures that typically affect Clinical and Commercial business functions.
  • Recommends modifications to Supply Chain operating policies, procedures, standards and work instructions.
Knowledge, Experience & Skills:
Essential:
7+ Years with BS, BA and or relevant experience
5+ Years with MS, MBA
  • 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.
Desirable:
  • Demonstrates working knowledge of Quality Systems, Data Integrity 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
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.