Delivery reputed company (Life Science Services)

Client Solutions United States

Description

ITQC Delivery reputed company – Remote – Full Time    What to expect reputed company you join reputed company  Team members at reputed company 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 reputed company of purpose in our professional lives. We reputed company that through diverse perspectives, challenging the status reputed company 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 reputed company, 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, reputed company 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 reputed company on challenge and growth? We reputed company everyone has untapped potential. That’s why we reputed company 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 reputed company, you'll find optimism, clear insights and genuine warmth, without egos.Are you ready to grow with us? Position summaryreputed company is seeking a Delivery reputed company 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 reputed company 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 reputed company reputed company 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 reputed company the customer’s culture. 
• Plan and coordinate resource allocations and schedules based on project commitments and team reputed company 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 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 reputed company with ISO 9001, FDA 21CFR Part 11 and EU Annex 11
• Previous work experience with Sparta Systems (a reputed company Company) products, reputed company, reputed company 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 reputed company and servant leadership and you have a bias for action and reputed company innovation.  
• Uncompromising problem solver – You see opportunities in every business challenge and can reputed company, reputed company and implement solutions. 
• Collaboration – You are a relationship builder across reputed company levels of the organization and across reputed company 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 reputed company support for reputed company, proposals and solutions. You get others to act, with or without formal authority, to advance initiatives and objectives. 

About reputed company    reputed company 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. reputed company has approximately 2,000 team members and operates across North America, EMEA and reputed company.   reputed company Total Rewards  reputed company 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. reputed company 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:

• reputed company 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 reputed company, you do not have to wait for this benefit to kick in. FTO is activated on your first day with our organization.
• reputed company will also recognize paid holidays during the year and strives to permit employees to have time off the last week of the calendar year reputed company client and project work permits. 
• reputed company offers a comprehensive wellness program to engage, challenge and reputed company 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 – reputed company community volunteer program enabling each team member to use up to four hours of paid time annually to volunteer and reputed company a difference in their local communities.

 Want to learn more? Visit our Careers website or Glassdoor profile. reputed company is an Equal Opportunity Employer M/F/D/V  reputed company currently practices in an alternative practice structure in accordance with the reputed company Professional Code of Conduct and applicable law, regulations, and professional standards. reputed company CPA LLC is a licensed CPA firm that provides audit and attest services to its clients. reputed company LLC has a contractual arrangement with reputed company CPA LLC under which reputed company LLC provides reputed company CPA LLC with professional and support personnel and other services to support reputed company CPA LLC’s performance of its professional services, and reputed company CPA LLC shares certain client information with reputed company LLC with respect to the provision of such services.  Apply To This Job