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? Position Summary 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. What will you do in this role? 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. What do you need to succeed in this role? 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 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 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 21CFR Part 11 and EU Annex 11 Previous work experience with Sparta Systems (a Honeywell Company) products, SAP, NetSuite and Dynamics ERP and automated testing software, is a PLUS In compliance with this state's pay transparency laws, the base compensation range for this role is $81,980.50 - $127,152.38 - $172,324.25. This is not a guarantee of compensation or salary, as final offer amount may vary based on several factors including but not limited to experience and geographic location. Compensation ranges for roles in our Government Services pillar are determined by contract with the specific government agency Sikich is servicing. In addition, specific skills/experience required are as follows: Servant Leader - You are hyper focused on engaging employees, fostering their development, and building a positive culture. Solutions Focused - You see opportunities in every business problem and can develop, articulate, and implement solutions. Collaboration - You are a relationship builder across all levels of the organization and across all business units. Instills Trust - You do what you say, and you follow through on commitments, you act with integrity, you are consistent and are perceived as credible. Impact & Influence Thinking - You gain support for ideas, proposals, and solutions, and get others to act, with or without formal authority, to advance initiatives/objectives. About Sikich Sikich offers the public and private sectors a varied 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 Total Rewards 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. Some examples of our many benefits: 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. We also offer: Flexible work arrangements Health, dental, vision, life, and accident/death/disability insurance options HSA employer contribution Nine (9) paid holidays annually. A robust paid Parental Bonding Leave program covering birth, adoption, and foster children. 401(k) with employer contributions CPA bonus with four (4) paid exam days & four (4) paid study days. Tuition reimbursement Generous employee referral bonus program Client referral bonus program Pet insurance FORCE - Sikich community volunteer program enabling each team member to use up to four hours of paid time annually to volunteer and make a difference in their localcommunities. Want to learn more? Visit our Careers website or Glassdoor profile. Sikich is an Equal Opportunity Employer M/F/D/V Sikich practices in an alternative practice structure in accordance with the AICPA Professional Code of Conduct and applicable law, regulations, and professional standards. Sikich CPA LLC is a licensed CPA firm that provides audit and attest services to its clients, and Sikich LLC and its subsidiaries provide tax and business advisory services to its clients. Sikich CPA LLC has a contractual arrangement with Sikich LLC under which Sikich LLC supports Sikich CPA LLC's performance of its professional services. Sikich LLC and its subsidiaries are not licensed CPA firms. "Sikich" is the brand name under which Sikich CPA LLC and Sikich LLC provide professional services. The entities under the Sikich brand are independently owned and are not liable for the services provided by any other entity providing services under the Sikich brand. The use of the terms "our company" and "we" and "us" and other similar terms denote the alternative practice structure of Sikich CPA LLC and Sikich LLC. Securities offered through Sikich Corporate Finance LLC, member FINRA/SIPC. Investment advisory services offered through Sikich Financial, an SEC Registered Investment Advisor. Copyright 2025 Sikich LLC. All rights reserved. #J-18808-Ljbffr Sikich