Head of Compliance Services

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 project management
• Experience working in a fast paced, high growth, results driven organization
• Experience in Project Management; managing numerous projects in excess of $5MM
• Prior supervisory experience managing at least 20 people and at least 3-5 direct reports

Skills

Proven experience and aptitude to meet, interact, and present in front of a wide range of customers with varying roles including:

• C-level executives
• Project managers and plant engineers
• Supervisor, operators
• Ability to strategically negotiate with clients and employees in high stress situations to resolve
  • Project and technical issues
  • Funding and change order discussions
  • Employee performance
• Possess a history of strong leadership, deep practical validation knowledge and a proven track record for timely project delivery, project management, cost control, and customer satisfaction. 
• Demonstrated ability to provide practical, specific guidance to colleagues regarding the knowledge of appropriate industry guidance and regulatory requirements
• Intermediate to expert skills with WORD, EXCEL and PROJECT
• Excellent English communication skills (written and verbal)
• Calm and collected leader with the ability to guide a team in stressful client services-oriented projects

Work Environment and Physical Demands:

• The Head of Service Line is expected to be supporting projects and business expansion activities at the client sites on a regular basis.  This position will require regular air and ground-based travel and overnight stays in hotels for multiple nights at a time.
• Business development opportunities and tight project requirements may demand significant hours beyond 40 and hours on the weekend.  Average work hours are approximately 45-50 hours/week. 
• This role must maintain average utilization on billable work.  Targets will be specifically defined in alignment with level and overall Gross Margins targets within your assigned accounts and projects.
• The Head of Service Line is required to sign an Employment agreement document and will be eligible for Senior Leadership Incentive programs.

Supervisory Requirements:

This position will be responsible for supervision of approximately 6-8+ direct reporting Delivery Directors.  Delivery Directors positions under the Head of Service Line are assigned based upon the size of the service line and number of accounts.  As a supervisor, the Head of Service Line is responsible for:

• Completing each direct report employee’s performance management plan
• Reviewing and approving the performance management plan for all employee’s in your group
• Providing bi-annual employee reviews to direct reports
• Provide comments and review executive recommendations for employee merit increases and yearly bonuses based upon corporate, division, and individual performance results
• Working with HR and leadership related to career development plans for all service line resources, including succession planning
• Identify any training gaps and work closely with HR and Training to resolve them.

This position requires cross-functional leadership responsibility to provide direction to employees, OEMs, contractors or clients as necessary to meet project goals and deadlines.

The position description merely illustrates the job and key aspects of the roles found within the Job Family. Duties, responsibilities, and activities may change with or without notice. Please note this job description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities that are required of the employee for the jobs listed below.