Head of Compliance Services

About this role

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues

• We commit to client success at every turn

• We have the courage to do the right thing

• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.

• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Job Family Overview:
The primary focus for this role includes ownership of one of the core service lines within Verista. The role is multi-faceted and includes development and business expansion of the service line at new customers, direct client interactions for penetration of the service line into existing customers, and Subject Matter Expert level project delivery/management in pharmaceutical/biotech space. Verista is structured as a matrixed organization and the service line leadership partners with client services leadership and sales to manage the overall delivery and client experience collectively.
The successful incumbent will drive the Verista Values and Mission - to be the leading provider of automation and compliance solutions across the entire regulated IT-OT (Information Technology and Operations Technology) Stack. This includes leading strategies and tactics related to ensure:

• Industry Leadership

• Customer Value

• Expansion & Growth

• Collaboration & Scale

This position requires understanding and expertise in these specific Service Line offerings:

• CSV / CSA

• CQV

• QMS Services

The position is to set an example of Verista Culture of hard work, positive attitude, commitment to satisfy the customer, and strong interpersonal skills.
Job Family Responsibilities:

•
Service Ownership

• Define the service line offerings and ensure adequate Delivery Director SME coverage.

• Own and align the Go-To-Market strategy of the service line. Work alongside Client Services, Delivery, Sales, Marketing and ELT to define the service and positioning in the marketplace.

• Define and manage annual P&L for the service line including revenue growth targets, margin and EBITDA.

• Co-owner of annual Strategic Account Management planning alongside Client Partners. The Head of Service Line is responsible for defining and executing on the plan to expand the service in strategically determined accounts.

• Direct internal management of a defined team of Delivery Directors to support the growth and execution objectives of the service line.

•
Delivering Project Work as Technical Subject Matter Expert

• Execute assigned technical project work in a subject matter expert capacity, in most cases as the project leader and/or project/program manager.

• Manage, execute and lead the day-to-day project activities of the designated project staff to ensure customers, sales and service delivery activities meet or exceed customer and company goals and expectations.

• As a technical leader in a professional services organization, this role is expected to carry a utilization target on billable client work dependent on level and portfolio size. Technical knowledge and ability to connect at all levels are essential to success in this role.

• Accountable for all solutioning/delivery methodologies – including the evolution to more managed service offerings utilizing scalable fundamentals related to people, process and technology.

• Ensure all services projects, initiatives, and processes are in conformance with organizations and customers established policies and objectives.

• Focus on ensuring standards and consistency with each employee and client.

•
Sales and New Engagement Activities

• Offer and support all lead generation activities for existing customers for projects to which you are assigned.

• Responsible for reviewing, assessing and defining all requirements for scope and estimation of contracts.

• Providing the technical depth and supporting relationship development with sales and client services members during the sales process.

• Support the Service Line Head on growth and strategic planning for expansion of dedicated services across existing and new customer base.

• Provide input on marketing, website, and strategies to facilitate growth.

Background Requirements:
This position requires the following skills/job knowledge:
Education

• Bachelor’s degree in technical (STEM) discipline
Industry Experience

• 15+ years of experience in GMP regulated environment with direct experience managing or leading applicable service line projects in a life sciences setting.

• 10+ years of professional services and consulting experience

• 7+ years of experience in professional services business development and customer relations

• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including:

• GAMP5

• Good Documentation Practice (GDP) in pharmaceutical environment

• ASTM-E2500

• ISO 14971 – risk management for medical devices

• ISPE Applied Risk Management for C&Q

• ISPE Science and Risk Based Approach for the delivery of facilities, systems and equipment

• ICH 8, 9, 10 - Knowledge of Risk management and Risk Analysis Tools

• Holistic understanding of process systems including work-processes, optimization methods, risk management, and…