Business Analyst Manager (Operations)

Descripción del trabajo

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.

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.

Job 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 (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

• Works on problems of moderate complexity where analysis of situations or data requires an evaluation of intangible variables

Knowledge & Skills

• 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 & Experience

• 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.