Business Analyst Manager (Operations)

$121,125 - $156,750/Yr

1010 Gilead Sciences, Inc.

Full-time - Mid Level

About the position

This role will represent the business on cross-functional teams delivering several projects in Gilead's Commercial Manufacturing & Packaging and Labeling Organization. The individual will be responsible for ensuring initiatives and projects meet core business requirements and that impacted business processes are updated for internal manufacturing and serialization & traceability. This includes managing global business processes applicable to both internal sites and external secondary packaging CMOs & 3PLs.

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.
• Represent Gilead's Serialization & Traceability function on global cross-functional teams and initiatives.
• Deliver robust system solutions to support Gilead's serialization & traceability related business processes (current or future).
• Assess the impact for any new product launches or packaging/labelling changes, identify and manage completion of tasks to address any gaps.
• Maintain serialization systems, policies, processes, and procedures ensuring compliance with regulatory requirements.
• Review, and/or implement changes to controlled documents as needed.

Requirements

• 6+ years relevant experience in 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.
• 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.
• 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.
• 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.

Nice-to-haves

• Familiarity with the technologies, strengths, and weaknesses of a wide variety of secondary packaging capabilities and manufacturers worldwide.
• Ability to collaborate cross-functionally.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives (eligibility may vary based on role).
• Paid time off.