[Hiring] Head of Compliance Services @Verista, Inc.

Role Description

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
• Subject Matter Expert level project delivery/management in pharmaceutical/biotech space

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.

Qualifications

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

Requirements

• 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

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement