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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’s contribution 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.
This role will represent the business on cross functional teams delivering several projects in Gilead’s Global Serialization & Traceability organization. In this role the individual will be responsible for ensuring initiatives and projects meet the core business requirements and impacted business processes are updated. These global business processes are applicable to both internal sites and business functions and external secondary packaging CMOs & 3PLs.
- Support the interpretation of both emerging and changing global serialization & traceability regulations and industry standards (e.g. GS1)
- Determining the impacts of these possible changes to Gilead systems and business processes and implementing business process solutions to support these new and changing regulatory requirements
- Manage assigned global cross-functional strategies and activities associated with the implementation and management of serialization activities for all commercial products across all manufacturing sites including all contract manufacturing organizations (CMOs).
- Compiles information from regulations, periodicals, catalogs, and other sources to keep informed on relevant market and competitor information.
- Reviews and provides feedback on serialization and traceability requirements in quality agreements.
- Represent Gilead’s Serialization & Traceability function on global cross functional teams and initiatives. Delivering robust system solutions to support Gilead’s serialization & traceability related business processes (current or future)
- Responsible for completion of high-level requirements gathering, use case development, documentation of user requirements and business process re-engineering
- Responsible for completion of business process change impact assessments for sustainment initiatives
- Manage the completion of business process and system regression testing as required by Gilead’s IT validation processes
- Planning, coordinating and execution of User Acceptance Testing of new and upgraded system solutions and the associated impacted business processes.
- Develops, implements and maintains oversight on policies and procedures for the operation of the Global Serialization & Traceability activities, ensuring all relevant business and regulatory requirements are met.
- Works on problems of moderate to advanced complexity where analysis of situations or data requires an evaluation of intangible variables.
- Provides leadership, direction and management of a team, to support execution of the Global Serialization and Traceability strategy.
- Provides oversight, guidance and management of personnel working on assigned projects and operational support processes.
- Creates and maintains a positive working environment to ensure high productivity, employee engagement and performance.
- Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
- Develops and implements strategies and goals for specific products or projects.
- Creates and effectively communicates supplier, subcontractor and/or vendor agreements and opportunities to the organization.
- May serve as liaison between the company and the various governmental agencies and/or audit agencies as required.
- Reviews, and/or implements changes to controlled documents as needed. May author sections of regulatory documents or position papers.
Knowledge & Skills
- Serialization and traceability expertise in a GMP environment including an in-depth understanding of SAP ATTP and the end to end serialization & aggregation business process and architecture from the packaging operations, warehousing, distribution and communication to both downstream trading partners and government systems.
- Able to develop solutions to a wide range of complex problems, which require the regular use of ingenuity and innovation.
- Exceptional verbal and written communication skills. Able to create written communication that is properly structured providing clear, concise messages that draw well supported conclusions and recommendations.
- Strong negotiation skills.
- Good organizational and time management skills, including working knowledge of basic project management tools and techniques.
- Ability to interact effectively with senior management.
- In-depth understanding and application of relevant principles, concepts, practices, and standards, along with an in-depth knowledge of industry practices and regulations.
- Solid working knowledge and expertise of relevant US, EU and international pharmaceutical cGMPs / regulations
- Able to apply established organizational policies, and interpret, execute and recommend modifications to department policies and procedures as needed.
- May require familiarity with the technologies, strengths and weaknesses of a wide variety of secondary packaging capabilities and manufacturers worldwide.
- Demonstrates in-depth knowledge and proficiency across multiple practices within Supply Chain and Commercial Manufacturing departments, to understand, coordinate and communicate competing demands.
- Ability to collaborate cross-functionally
Education & Experience
- 8+ years relevant experience in related field and a BS or BA; or
- 6+ years of relevant experience and a MA/MBA.
- Experience in pharmaceutical operations/cGMP environment highly desirable.