At Perficient you’ll deliver mission-critical technology and business solutions to Fortune 500 companies and some of the most recognized brands on the planet. And you’ll do it with cutting-edge technologies, thanks to our close partnerships with the world’s biggest vendors. Our network of offices across North America, as well as locations in India and China, will give you the opportunity to spread your wings, too.

We’re proud to be publicly recognized as a “Top Workplace” year after year. This is due, in no small part, to our entrepreneurial attitude and collaborative spirit that sets us apart and keeps our colleagues impassioned, driven, and fulfilled.

About Our Life Sciences Business Unit / Practice

The Life Sciences Business Unit provides strategic technology and consulting services to pharmaceutical, biotechnology, and medical device companies, as well as contract research organizations (CROs) and academic institutions (AROs). Our experience working with more than 200 life sciences companies has helped us form long-lasting relationships that enable companies to improve their clinical, safety, and business operations while reducing costs.

Perficient currently has a career opportunity for a remote Lead Business Consultant with a background in Life Sciences Computer Systems Validation.

Job Overview:

The role of the Computer Systems Validation (CSV) Lead Business Consultant is for individuals passionate about identifying and delivering the right Business solution for each client. Our Lead Business Consultants have a keen Business orientation with an understanding of how system validation and quality can be effectively applied to meet the business needs of customers in a regulatory industry.

Our Lead Business Consultants make decisions using their experience and guide their teams and clients through handling validation of computer systems.  The specific responsibilities may vary for each client and each project. The key to the success of our Lead Business Consultants is the willingness and desire to quickly learn the client’s unique requirements of each engagement and to fill whatever needs may be required to best support our clients.

A Lead CSV Business Consultant is goal oriented, thrives in challenging environments and accomplishes difficult assignments without significant supervision and instruction. Our Consultants can mutli-task, handle the stress of being accountable for delivery and: complete goals on time, practice strong attention to detail, persevere through tough obstacles, and do not get easily discouraged.

The Lead CSV Business Consultant is a key delivery point of contact and will be involved in the strategic planning of an engagement or helping the client make decisions about their future validation needs. Once a project has begun, the Lead CSV Business Consultant will facilitate key requirements with stakeholders and customers using regulatory, standard and User Experience techniques. The Lead Business Consultant may be responsible for System Assessments, Plans, Protocols, Requirement Specifications, Test Execution Reviews, and Summary Reports.

The Lead CSV Business Consultant works directly with Project Managers and assists with daily operations exercising time management, clear and effective communication and collaboration in a fast-paced environment to ensure the successful delivery of projects. The Lead CSV Business Consultant will interface with Perficient technical and business delivery personnel, as well as vendors and customers on a regular basis.  Most of the meetings will be virtual. The Lead CSV Business Consultant will mentor junior Consultants.

• Build trusted client relationships through proactive account management and effective project delivery.
• Ensure that all department responsibilities are performed and documented accurately, timely and in compliance with approved policies and procedures, GxP and FDA requirements, and industry best practices.
• Maintains regular client communication and satisfaction, ensuring opportunities and challenges are addressed in a timely manner.
• Present proposed solutions related to audits, validation and quality to internal team as well as customers.
• Author and Review validation documentation (plans, protocols, test suites, reports, etc.).
• Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented.
• Coordinates client specific validation activities with practice leads and project managers.
• Enforce QA requirements for IT quality systems with potential GxP impact.
• Support GxP decisions/strategies during validation projects.
• Document applicable deviations and documentation anomalies for computer systems undergoing validation.
• Provides Leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met.
• Review requirements, traceability matrices, test suites and test executions.
• Instills team commitment to company delivery methodologies and practices.
• Other duties as required for the Lead Business Consultant position.

• Bachelor’s Degree.
• 5-7 years of professional CSV, QA or business analysis experience, with strong relationship management, account management, and support experience.
• Demonstrated ability and understanding on the development and execution of qualification protocols (IQ, OQ and PQ) and other validation lifecycle documents.
• Life Sciences industry experience.

• Strong understanding of GxP, FDA, OSHA, 21 CFR Part 11 and other local, state and federal regulatory requirements associated with the Life Sciences industry.
• Ability to demonstrate competencies in current technology and be capable of making recommendations for technological improvements in order to achieve a validated state.

• Ability to provide recommendations for best practices and ensure follow thru and verifications are complete as appropriate.
• Skilled ability to obtain, understand and respond strategically to client needs.
• Highly detail oriented, well organized, and able to coordinate multiple projects simultaneously.
• Strong analytical, problem solving and conflict resolution skills.
• Energetic, motivated, service-oriented, and be able to multi task.
• Proven track record of delivering on time, on budget, and meeting client commitments.
• Excellent listening, oral, and written communication skills.
• Excellent facilitation, presentation, and reporting skills.
• Excellent interpersonal and teamwork skills with individuals across multiple timezones.
• Flexibility for occasional travel up to 20 percent as needed.
• Flexibility to work evenings or weekends as needed.

Preferred skills and education:

• Master’s Degree.
• Experience with the Oracle Life Sciences Platform, including but not limited to: Oracle Clinical, Remote Data Capture, Thesaurus Management System, eLoader, and NMAT.
• Consulting industry experience working with external clients.
• Strong background in CSV or QA.
• Experience working in a waterfall environment.
• Project management experience.
• Experience with International Standards such as EU Annex 11, Privacy Shield, ICH, and EMA.

Perficient full-time employees receive complete and competitive benefits. We offer a collaborative work environment, competitive compensation, generous work/life opportunities and an outstanding benefits package that includes paid time off plus holidays. In addition, all colleagues are eligible for a number of rewards and recognition programs including billable bonus opportunities. Encouraging a healthy work/life balance and providing our colleagues great benefits are just part of what makes Perficient a great place to work. 

More About Perficient

enterprise customers throughout North America. With unparalleled information technology, management consulting and creative capabilities, Perficient and its Perficient Digital agency deliver vision, execution and value with outstanding digital experience, business optimization and industry solutions.

Our work enables clients to improve productivity and competitiveness; grow and strengthen relationships with customers, suppliers and partners; and reduce costs.  Perficient's professionals serve clients from a network of offices across North America and offshore locations in India and China. Traded on the Nasdaq Global Select Market, Perficient is a member of the Russell 2000 index and the S&P SmallCap 600 index.

Perficient is an award-winning IBM Premier Business Partner, a Microsoft National Service Provider and Gold Certified Partner, an Oracle Platinum Partner, an Adobe Business Solution Partner, and a Salesforce Gold Consulting Partner.

Perficient is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national, origin, disability status, protected veteran status, or any other characteristic protected by law.

Disclaimer:  The above statements are not intended to be a complete statement of job content, rather to act as a guide to the essential functions performed by the employee assigned to this classification.  Management retains the discretion to add or change the duties of the position at any time.