Business Analyst Manager (Operations)

$121,125 - $156,750/Yr

Gilead Sciences - Frederick, MD

Full-time - Mid Level

Frederick, MD

Chemical Manufacturing

About the position

The Business Analyst Manager (Operations) at Gilead is responsible for leading cross-functional teams to deliver projects within the Commercial Manufacturing & Packaging and Labeling Organization. This role focuses on ensuring that business initiatives meet core requirements and that impacted processes are updated for internal manufacturing and serialization & traceability. The position plays a critical role in supporting serialization operations and compliance with regulatory requirements, contributing to Gilead's mission of delivering life-saving therapies.

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 (CMO's) and Authorized Trading Partners (ATP's).
• 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.
• 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.
• 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.
• 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

• Experience in pharmaceutical operations/cGMP environment highly desirable.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.