Associate Director, Business Process Analyst

Associate Director, Business Process Analyst

Create business process models within the process modeling methodology framework by analyzing a number of sources (SMEs, documentation and previous Visio/SIPOC maps). In addition, the Process Engineer will be expected to facilitate workshops, fact‑finding interviews, project management activities, and other necessary activities to gather and synthesize information into their process models.

• Exceptional facilitation skills to gather SME input to design clear articulation of end‑to‑end process for assigned business process – must be able to work with a variety of stakeholders at all levels within Research and Development and drive alignment to a common vision / goal.
• Expertise in Business Process Management (BPM) methodologies, techniques, and methods, including but not limited to Six Sigma, Lean, BP Trends, Hammer and Rummler‑Brache and / or Agile.
• Create Signavio model design and accurate process attributes.
• Excellent analytical and abstraction reasoning skills, as well as problem solving ability to drive productive process mapping working sessions with stakeholders.
• Strong understanding of procedural document hierarchy to translate (e.g., SOP) into L1-L3 process maps.
• Reconciliation – able to reconcile procedure‑based maps with actual ways of working.
• Gap Analysis – determine and validate issues, risks, gaps, bottlenecks.
• Process Profiles: creation of SIPOC‑based process profiles.
• Creation of To‑be Process Maps – leverage above materials to create and validate future state process flows; able to analyze and translate live workshop discussion and sources (SME interviews, documentation and previous Visio/SIPOC maps) into process flows.
• Proactively engage system owners and IT for system implementation and integration with business.
• Knowledge and application of core process mapping methodologies and tools (e.g., flow charts, value stream maps, SIPOC, swimlane diagrams).
• Strong understanding of risk management principles; ability to define, minimize and mitigate risks during process mapping.
• Strong understanding of capability layers and ability to distinguish business process from system functionality and requirements.
• SME to enable documentation – participate in creation and review of new / updated GxP procedures.
• Advanced skill level with Microsoft Visio.
• Experience with Signavio – Business Process Management System.
• Advanced skill level in Microsoft Word, PowerPoint and Excel.
• Experience with project management approaches and tools with specific experience with MS Project and Smart Sheets preferred.
• Exceptional listening and communication skills, both written and verbal.
• Prior experience as business analyst or business / systems architect.
• Experience writing technical documents such as policies, standard operating procedures, work instructions and / or detailed manuals.

• U.S. Education & Experience
• BA/BS with 8+ years’ relevant experience.
• 4+ years experience / expertise in Drug Development including all key functions involved in the various stages of drug development from early research through post‑marketing.
• Strong experience in Good Clinical and Good Pharmacovigilance Practices and knowledge of evolving regulations, such as ICH E6 R3.
• Proven experience advising business functions in the biopharma industry on quality and compliance requirements and continuous improvement.
• Experience working across a broad spectrum of quality and/or compliance activities, including authoring SOPs, leading QMS projects, and training others on quality and/or compliance requirements.
• Experience supporting internal and external GxP audits and inspections is preferred.
• Experience setting up a Business Process Owner Center of Excellence.
• Experience participating in cross‑functional projects and teams with responsibilities related to clinical trials or other drug development activities.
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is preferred.
• Knowledge & Other Requirements
• Demonstrates advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and / or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Strong negotiation and conflict resolution skills.
• When needed, ability to travel.

Full Time / Part Time:
Full‑Time. Job Level: Associate Director.