Business Operations Manager

1 day ago

Foster City, California, United States BioSpace, Inc. Full time
Job Overview

This role will represent the business on cross-functional teams delivering several projects in Gilead's Commercial Manufacturing & Packaging and Labeling 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 for internal manufacturing and serialization & traceability.

These global business processes are applicable to both internal sites and business functions and external secondary packaging CMOs & 3PLs.

Key Responsibilities
  • Provide support to Gilead's Serialization Level 4 (Enterprise) systems and operational processes, including facilitation of the weekly Global Serialization Operations Meeting.
  • Support Serialization day-to-day operations business process issues, investigations, and resolutions.
  • Support Serialization data exchange with Gilead's contract manufacturing organizations (CMOs) and Authorized Trading Partners (ATPs).
  • Define, track, and report on metrics and SLAs as required to ensure operational processes meet business needs.
Requirements
  • Pharmaceutical manufacturing and packaging operations knowledge, including systems, business processes, and controls.
  • 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 from the packaging operations, warehousing, distribution, and communication to both downstream trading partners and government systems.
  • Demonstrates knowledge and proficiency across multiple practices within Supply Chain and Commercial Manufacturing departments, to understand, coordinate, and communicate competing demands.
  • In-depth understanding and working knowledge of Software Development Lifecycle (SDLC), including basic knowledge of risk assessments, computerized systems validation processes, and data integrity controls.
  • 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.
  • Good organizational and time management skills, including working knowledge of basic project management tools and techniques.
  • Solid working knowledge and expertise of relevant US, EU, and international pharmaceutical cGMPs / regulations.
  • May require familiarity with the technologies, strengths, and weaknesses of a wide variety of secondary packaging capabilities and manufacturers worldwide.
  • Ability to collaborate cross-functionally.
Education and Experience
  • 6+ years of relevant experience in a related field and a BS or BA; or
  • 4+ years of relevant experience and a MA/MBA.
  • Experience in pharmaceutical operations/cGMP environment highly desirable.
Benefits
  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Equal Employment Opportunity

Gilead Sciences Inc. is an equal opportunity employer, committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental 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.

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