(position on hold) Executive Director/ Sr. Director, IT/GxP Research & Development Business Partner (Bio/Pharma/Life)- Westlake Village, Ca 91361 Contract or Contract to Hire

From Client: ” Top priority hire.

Must have GxP Systems, Life Sciences/BioPharma. 15 + Years. Seasoned pro. Will cover R&D and Manufacturing. Divide and conquer with the Director DKKD Staffing placed, though roles will differ.

Experience building systems.

Need someone who can handle their own with Execs, Senior Leadership and represent IT, be able to start ASAP and must live locally”.

Please provide your # of years’ experience, last year worked on and elaborate as necessary (per bullet)

• Worked in Life Sciences/BioTech/BioPharma in an IT department:
• Experience in Regulated IT, GxP, CSV, Systems Validation, Validation of Computer Systems:
• Experience building systems for an emerging Biotech:
• Experience managing vendors and contractors:
• Comfortable communicating at all levels:
• Able to influence the business/ Relationship Management:

Job Summary

We are looking for an outstanding individual to join our exciting biotech team located in Westlake Village, California! The Executive Director IT – GxP Systems is responsible for the technology strategic direction for R&D and Manufacturing functions including Clinical, Regulatory, Drug Safety, Research, Operations and Quality. The role will be a key member of the IT Leadership Team and assure that all technology initiatives are delivered with the appropriate focus on corporate strategic goals, IT strategy alignment, strong focus on compliance and appropriate post-go live support models.

Roles & Responsibilities

• In partnership with R&D and Manufacturing leadership, develop strategic investment roadmap identifying business capability gaps and the target solutions/platforms to address critical gaps
• Build trust with senior R&D and Manufacturing leadership by demonstrating a deep understanding of all business functions and advocating for strategic solutions instead of point solutions
• Identify opportunities where technology can build competitive advantage and educate both IT and R&D and Manufacturing leadership teams
• Provide guidance and counsel on technology available that drives capability improvements consistent with business direction
• Prepare business case for IT investment and assist in preparation/presentation to R&D Leadership and Manufacturing Leadership Teams, VP IT and the Executive Team
• Manage and help set R&D and Manufacturing leadership expectations in regard to timing and value of each technology investment
• Facilitate the negotiation of requirements across multiple stakeholders and translate those requirements into Functional Requirements document specifications
• Partner with IT team members to manage on-time and on-budget project delivery of new systems driving business capability improvements. Assure that project delivers on stated goals and meets any pre-defined metrics
• Develop required test plans and assist in the execution of test plans as needed
• As the IT Single Point of Contact to R&D and Manufacturing, ensure that expectations have been met through delivery of services or projects
• Assure that GxP compliance requirements are properly assessed and that appropriate Computer Systems Validation is implemented for both new solutions and improvements to existing systems

 Technical Knowledge Required

Knowledge of technologies critical within a biotech R&D organization. Examples include key technologies such as Clinical Electronic Data Capture, Electronic Trial Master File, Drug Safety Management, Quality Management Systems, Regulatory Information Management and Submission Publishing

Education & Licenses and Experience

Bachelor’s degree in the field of computer science or information systems or related field required or equivalent combination of education and experience required. Minimum of 15 years’ IT experience in positions of increasing responsibility, with a minimum of 5 years’ experience in a leadership role.

Additional Competencies & Skills

• Experience in Life Sciences (Biotech, Pharmaceuticals, Medical Device) industry including implementation of solutions with a focus on GxP compliance
• Demonstrated ability to partner with business team leaders and create alignment on technology investment. Experience with R&D and Manufacturing functions required
• Success managing IT growth in rapidly growing companies
• Demonstrated ability to successfully lead high-profile, complex projects and implement with minimum disruption to business
• Ability to rapidly assimilate and apply new technical knowledge based on departmental and corporate goals and objectives, work successfully in cross functional teams, effectively identify problems and develop flexible, scalable and cost-effective solutions.
• Strong technical knowledge and practical experience in defining, implementing and managing business and technical solutions
• Strong written and oral communication skills, possessing the ability to communicate at both a technical level as well as at a business subject area level\
• Ability to communicate complex technology concepts to executive management and the user community in a way that is connected to business objectives

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