Delivery Lead (Life Science Services)
Client Solutions
United States
Description
ITQC Delivery Lead – Remote – Full Time 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 diverse 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 and agile practitioners who thrive on challenge and growth? We believe everyone has untapped potential. That’s why we lead with vision and act fast, pairing deep expertise with practical solutions. Our teams cut through complexity and deliver real impact. It's our hope that you find more than just a job. At Sikich, you'll find optimism, clear insights and genuine warmth, without egos.Are you ready to grow with us? Position summarySikich 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.Responsibilities 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 DeliveryReview 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. Requirements BS/BA or 10+ years relevant experience7+ 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 skillsExperience 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 LIMSExperience with systems integrations and data migration/extraction, e.g., to/from TrackWise and TrackWise DigitalAbility to quickly learn technologies and product functionality.Entrepreneurial by nature with a strong sense of ownershipProblem-solving and analytical skills.Experience managing competing priorities in a fast-paced team environmentExperience with organizations who comply with ISO 9001, FDA 21CFR Part 11 and EU Annex 11Previous 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 midpoint of the salary range for this role is $125,000. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location.In addition, specific skills/experience required are as follows: Values driven – You embody and model absolute integrity and servant leadership and you have a bias for action and continuous innovation. Uncompromising problem solver – You see opportunities in every business challenge 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, without ego, and you follow through on commitments consistently and credibly. Impact & influence – You are relentlessly focused on making a difference and can gain support for ideas, proposals and solutions. You get others to act, with or without formal authority, to advance initiatives and objectives. About Sikich 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. 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 arrangementsHealth, dental, vision, life, and accident/death/disability insurance optionsHSA employer contributionNine (9) paid holidays annually.A robust paid Parental Bonding Leave program covering birth, adoption, and foster children.401(k) with employer contributionsCPA bonus with four (4) paid exam days & four (4) paid study days.Tuition reimbursementGenerous employee referral bonus programClient referral bonus programPet insuranceFORCE – 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 local communities. Want to learn more? Visit our Careers website or Glassdoor profile. Sikich is an Equal Opportunity Employer M/F/D/V Sikich currently 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. Sikich LLC has a contractual arrangement with Sikich CPA LLC under which Sikich LLC provides Sikich CPA LLC with professional and support personnel and other services to support Sikich CPA LLC’s performance of its professional services, and Sikich CPA LLC shares certain client information with Sikich LLC with respect to the provision of such services.
Apply Now
United States
Description
ITQC Delivery Lead – Remote – Full Time 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 diverse 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 and agile practitioners who thrive on challenge and growth? We believe everyone has untapped potential. That’s why we lead with vision and act fast, pairing deep expertise with practical solutions. Our teams cut through complexity and deliver real impact. It's our hope that you find more than just a job. At Sikich, you'll find optimism, clear insights and genuine warmth, without egos.Are you ready to grow with us? Position summarySikich 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.Responsibilities 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 DeliveryReview 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. Requirements BS/BA or 10+ years relevant experience7+ 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 skillsExperience 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 LIMSExperience with systems integrations and data migration/extraction, e.g., to/from TrackWise and TrackWise DigitalAbility to quickly learn technologies and product functionality.Entrepreneurial by nature with a strong sense of ownershipProblem-solving and analytical skills.Experience managing competing priorities in a fast-paced team environmentExperience with organizations who comply with ISO 9001, FDA 21CFR Part 11 and EU Annex 11Previous 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 midpoint of the salary range for this role is $125,000. This is not a guarantee of compensation or salary, as final offer amount may vary based on factors including but not limited to experience and geographic location.In addition, specific skills/experience required are as follows: Values driven – You embody and model absolute integrity and servant leadership and you have a bias for action and continuous innovation. Uncompromising problem solver – You see opportunities in every business challenge 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, without ego, and you follow through on commitments consistently and credibly. Impact & influence – You are relentlessly focused on making a difference and can gain support for ideas, proposals and solutions. You get others to act, with or without formal authority, to advance initiatives and objectives. About Sikich 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. 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 arrangementsHealth, dental, vision, life, and accident/death/disability insurance optionsHSA employer contributionNine (9) paid holidays annually.A robust paid Parental Bonding Leave program covering birth, adoption, and foster children.401(k) with employer contributionsCPA bonus with four (4) paid exam days & four (4) paid study days.Tuition reimbursementGenerous employee referral bonus programClient referral bonus programPet insuranceFORCE – 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 local communities. Want to learn more? Visit our Careers website or Glassdoor profile. Sikich is an Equal Opportunity Employer M/F/D/V Sikich currently 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. Sikich LLC has a contractual arrangement with Sikich CPA LLC under which Sikich LLC provides Sikich CPA LLC with professional and support personnel and other services to support Sikich CPA LLC’s performance of its professional services, and Sikich CPA LLC shares certain client information with Sikich LLC with respect to the provision of such services.
Apply Now