Senior Manager – Process Engineering
| Company | Gilead Sciences |
|---|---|
| Location | San Mateo, CA, USA, Parsippany-Troy Hills, NJ, USA |
| Salary | $157590 – $203940 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- 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
Responsibilities
- Create business process models within the process modeling methodology framework by analyzing a number of sources (SMEs, documentation and previous Visio/SIPOC maps)
- 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, swimland 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 SmartSheets 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
Preferred Qualifications
- Experience supporting internal and external GxP audits and inspections is preferred
- Experience working with one or more Gilead therapeutic areas and varying stages of drug development is preferred