Lucas Group is hiring an Associate Director of Business Applications for a Biomedical company on the forefront of molecular testing. This organization has received multiple awards and grants for their work done toward testing for COVID-19. Now they need a knowledgeable and versatile IT leader who is not afraid to roll up their sleeves to come in and help build up the core of their business applications.
The Associate Director, Business Applications will lead business application strategy, design, implementation and support. The successful candidate will possess a proven track record of assessing, building, and managing technology to support the business application requirements for a rapidly growing company. The Associate Director will be responsible for overseeing all business applications across the company, including HR, Finance, R&D, Clinical Development, Regulatory Operations, Commercial Sales as well as compliance programs including SOX and GxP systems.
Responsibilities:
- Create, seek buy-in and implement an enterprise-wide business applications roadmap that supports the rapidly expanding business.
- Actively partner as a liaison to the functional leaders and translates their business requirements into technical solutions, processes and procedures as appropriate.
- Enterprise system architect across multiple initiatives, taking ownership for identified platforms/systems and collaborating closely with various business departments, other IT resources and vendors.
- Provide leadership in system delivery/implementation, ensuring GxP and SOX compliance are achieved on all key systems.
- Develop project plans with clearly defined timelines and business outcomes and implement necessary risk mitigation strategies and lead project execution.
- Assess new technologies and vendors through pilots and site visits.
- Participate in portfolio and budget planning.
- Responsible for providing day-to-day support, system administration, availability and performance monitoring, and continuous improvement activities for systems in portfolio.
- Manage the development, review, and approvals process for system level risk assessments, IT change controls, periodic reviews, and user account reviews for systems in portfolio.
- Oversee business application elements of SOX compliance including coordination with internal/external auditors on quarterly and annual reviews.
Qualifications & Experience
- Proficient expertise in mid-tier ERP application platforms including NetSuite and MS Dynamics and MS Office Suite (PowerPoint, Excel, Visio, Project, SharePoint, Outlook).
- ERP implementation background.
- Strong CRM implementation experience, preferably Salesforce.
- Must communicate exceptionally well, both in writing and verbally, including communicating with dispersed/remote teams.
- Demonstrates active listening, by summarizing what is heard and asking questions to check understanding.
- Able to execute well and within tight timelines and within reasonable budgets.
- Demonstrates leadership by taking initiative.
- B.S. degree from an accredited, four-year college or university preferably in information systems; advanced degree preferred.
- 10+ years of relevant work experience in biotech/pharmaceuticals, with at least 5 years working on business transformation and/or IT implementation/management.
- Hands-on knowledge of procedures/ best practices related to FDA Regulations, SOX, EU GMP Annex 11, 21 CFR Part 11, CSV, GAMP 5, cGxP practices required.
- Knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q9 and Q10) particularly as it applies to regulated software development.
- Hands on experience with ERP (Netsuite and/or MS Dynamics) for Finance/CRM/Supply Chain/Manufacturing needed. Must be familiar with Order-to-Cash, Supply Chain processes operating in a global environment.
- Understands relational databases and reporting tools (PowerBI or Tableau).
- Experience in system integration, Dataware-house (Azure/Snowflake) and EDI tools (Snaplogic).
- Familiar with System lifecycle (SLC) experience in a regulated environment.
- Familiar with Operating Systems, Infrastructure, VMWare Virtualization, and cloud-hosted technologies (Microsoft/AWS). Ability to articulate technical problems and business value to a wide business audience.
- Ability to troubleshoot issues and work independently with minimal supervision.
- Builds relationships and partnerships with key internal and external stakeholders
- Must be able to understand and mediate needs of multiple stakeholders, who may have competing priorities.
- Proven ability working in a high growth environment and leading multi-level / cross functional teams including coordinating vendors and third-party resources as necessary.
- Independently prioritizes project specific priorities with daily and/or ad hoc requests while still maintaining high quality of deliverables.
- Keeps stakeholders sufficiently informed on progress with initiatives or deliverables.
- Consistently demonstrates core values of confidentiality, transparency and trust.
