Delivery Lead; Life Sciences Services

Delivery Lead (Life Sciences Services) - (US - Remote)

What to expect when you join Sikich

Team members at Sikich have a lot in common while also being part of a rich and varied group of contributors, creating a distinct and thriving culture. Chief among our commonalities is a desire for growth and a shared unity of purpose in our professional lives. We believe that through different perspectives, challenging the status quo and rewarding action, we accelerate innovation and drive growth - for our clients, for ourselves and for our communities.

The professional services landscape continues to evolve. For Sikich, this means we have an opportunity to further cement our leadership position in this industry and continue to grow our organization in increasingly exciting ways. This growth is meaningful for every team member at our company because larger companies simply see more interesting client opportunities and can attract impressively talented individuals like you.

Through a dedicated focus on key business priorities and intentionally creating a rewarding employee experience, Sikich has developed into a highly regarded provider of professional services and a sought-after employer of choice.

Do you want to work with other skilled practitioners and serve clients in a way that makes a difference? Are you seeking a supportive environment backed by a deep and extensive set of skillsets? Are you ready to make an impact and be acknowledged for your contributions? If you answered yes to these questions, we see a mutually beneficial and gratifying relationship on the horizon!

Are you ready to grow with us?

Sikich is seeking a Delivery Lead to support pre-sales activities and manage strategic service engagements for the IT Quality, validation, and compliance in the Life Science industry. Candidates should have a minimum of 10 years of experience in CSV/CSA in FDA or EMA regulated environments.

• Work with customers, partners and other Sikich practices sales team and project leads to:
• Estimate costs of potential projects, support sales efforts and customer engagements.
• Author & review SOWs to create profitable customer engagements.
• Provide subject matter expertise to customers & members of the ITQC team.
• Provide guidance to customers on how to best leverage Sikich best practice and technology to meet customer defined business goals and objectives.
• Work with Sales team to guide the hand-off between Sales and Delivery
• Review customer business processes and goals, identify improvements and advise/ participate in the discussion of business requirements.
• Manage and execute strategic projects engagements along with implementation team by:
  • Managing strategic projects as billable Validation Project Manager (50-60% billable)
    Working with practice leads and resources manager to prioritize work activities of team members.
  • Providing team with training on technical knowledge, how to understand customer priorities, and methods to meet expectations within the customer's culture.
  • Plan and coordinate resource allocations and schedules based on project commitments and team skill sets.
  • Establish, maintain, and expand productive, professional relationships with key personnel in assigned and new partner accounts.
  • Provide guidance and support to the project implementation team.

• BS/BA or 10+ years relevant experience
• 7+ years of experience in CSV/CSA and GAMP 5 risk-based validation in FDA or EMA regulated environments Ability to apply validation best practices for Life Science solutions.
• Excellent documentation and communication skills
• Experience using testing management tools such as HPAL, JIRA, etc.
• Experience using digital validation tools such as Val Genesis, Kneat, etc.
• Experience with regulated solutions for life science companies including ERP, EQMS and LIMS
• Experience with systems integrations and data migration/extraction, e.g., to/from Track Wise and Track Wise Digital
• Ability to quickly learn technologies and product functionality.
• Entrepreneurial by nature with a strong sense of ownership
• Problem-solving and analytical skills.
• Experience managing competing priorities in a fast-paced team environment
• Experience with organizations who comply with ISO 9001, FDA 21
  
  CFR Part 11 and EU Annex 11
• Previous work experience with Sparta Systems (a Honeywell Company) products, SAP, Net Suite and Dynamics ERP and automated testing software, is a PLUS

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