Delivery Lead (Life Science Services)

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.

Experience using testing management tools such as HPAL, JIRA, etc.

Experience using digital validation tools such as ValGenesis, 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 TrackWise and TrackWise Digital

Experience with organizations who comply with ISO 9001, FDA 21CFR Part 11 and EU Annex 11

Our team members enjoy expansive benefits ranging from competitive compensation and insurance options to wellness programs and a flexible time off policy, to name only a few. Sikich also takes pride in prioritizing team members’ health, total wellbeing and time spent with family, friends and in the pursuit of personal goals, hobbies, and endeavors.

Sikich maintains a Flexible Time Off (FTO) Policy. We encourage every full-time employee, as your role permits, to utilize paid time off (personal time, mental/physical health care, vacation, sick leave, etc.). Waiting for time off to accrue is common at other companies. At Sikich, you do not have to wait for this benefit to kick in. FTO is activated on your first day with our organization.

Sikich will also recognize paid holidays during the year and strives to permit employees to have time off the last week of the calendar year when client and project work permits.

Sikich offers a comprehensive wellness program to engage, challenge and empower team members to take responsibility for their wellbeing. Activities can be tracked through our wellness provider to obtain gift cards and other rewards.

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.

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.

Sikich

offers the public and private sectors a diverse platform of professional services across consulting, technology and compliance. Highly specialized and hands-on teams deliver integrated solutions rooted in deep industry experience. Our approach is strategically and thoughtfully designed to help our clients, teams and communities accelerate success.

Sikich has approximately 2,000 team members and operates across North America, EMEA and APAC.