Verista, Inc.
Verista, Inc.
Verista, Inc. provides consulting and technical services for companies in life sciences, biotechnology, pharmaceuticals, and medical devices. Its work spans commissioning, qualification and validation; vision and systems integration; data analytics; cybersecurity; digital transformation; regulatory compliance; and infrastructure management. Verista also supports managed services, program and project delivery, and digital strategy, helping clients address quality and compliance across the product lifecycle. The company’s listed industries include consulting, manufacturing, and food and beverage.

Head of Compliance Services

Lead Verista’s life sciences compliance consulting service line, overseeing client delivery, business growth, and profit and loss. Guide pharmaceutical and biotechnology projects while managing teams and strategic accounts.

Apraksts

  • Lead and shape a core compliance service line at Verista.
  • Grow the service line by winning new clients and expanding existing accounts.
  • Act as a subject matter expert and lead pharmaceutical and biotechnology project delivery.
  • Set service offerings and ensure Delivery Directors have the necessary subject matter expertise.
  • Align go-to-market plans with Client Services, Delivery, Sales, Marketing, and the executive leadership team.
  • Manage annual service-line profit and loss, revenue targets, margins, and EBITDA.
  • Plan strategic account management with colleagues and carry out account expansion plans.
  • Manage six or more Delivery Directors and support service-line growth and execution.
  • Contribute technical expertise and lead projects or programs as a subject matter expert, project lead, or project manager.
  • Oversee project staff’s daily work to meet customer, sales, and delivery goals.
  • Meet utilization targets through billable client work.
  • Create solution and delivery methods, including scalable managed services.
  • Ensure projects and processes meet organizational and customer policies and objectives.
  • Support lead generation, contract scoping and estimates, sales, and relationship building.
  • Contribute to growth and strategic planning for current and prospective customers.
  • Advise on marketing, website, and growth strategies.
  • Prepare performance plans and conduct twice-yearly reviews for direct reports.
  • Review recommendations for merit increases and bonuses.
  • Partner with HR and leadership on career development and succession planning.
  • Identify training needs and coordinate solutions with HR and Training.
  • Coordinate employees, OEMs, contractors, and clients across functions to meet project goals and deadlines.

Prasības

  • Bachelor’s degree in a technical STEM discipline.
  • At least 15 years in a GMP-regulated environment, including direct experience leading relevant service-line projects in life sciences.
  • At least 10 years of professional services and consulting experience.
  • At least 7 years in professional services business development and customer relations.
  • Expertise in FDA regulations, ISPE guidelines, and ISO standards.
  • Knowledge of GAMP 5.
  • Knowledge of Good Documentation Practice in a pharmaceutical environment.
  • Knowledge of ASTM E2500.
  • Knowledge of ISO 14971 risk management for medical devices.
  • Knowledge of ISPE Applied Risk Management for commissioning and qualification.
  • Knowledge of ISPE’s science- and risk-based approach to facilities, systems, and equipment.
  • Knowledge of ICH Q8, Q9, and Q10, plus risk management and risk analysis tools.
  • Broad understanding of process systems, work processes, optimization methods, risk management, and project management.
  • Experience in a fast-paced, high-growth, results-driven organization.
  • Experience managing multiple projects valued above $5 million.
  • Prior supervisory experience managing at least 20 people, including 3–5 direct reports.
  • Ability to meet with and present to C-level executives, project managers, plant engineers, supervisors, and operators.
  • Ability to negotiate strategically with clients and employees in high-pressure situations.
  • Strong leadership, practical validation expertise, and a record of timely project delivery, cost control, project management, and customer satisfaction.
  • Ability to provide practical guidance on industry standards and regulatory requirements.
  • Intermediate to expert proficiency in Word, Excel, and Project.
  • Excellent written and spoken English communication skills.
  • Ability to lead calmly during stressful client-service projects.
  • Willingness to travel regularly to client sites, including by air and ground, with overnight hotel stays.
  • Ability to work approximately 45–50 hours per week, including weekends when needed.
  • Must sign an employment agreement.

Priekšrocības

  • Competitive compensation and performance-based incentive programs.
  • Company-paid life, short-term disability, and long-term disability insurance.
  • Medical, dental, and vision insurance.
  • Flexible spending, dependent care, and commuter benefits.
  • Supplemental life, hospital, critical illness, and legal insurance.
  • Health savings account.
  • 401(k) retirement plan with employer matching.
  • Paid time off with rollover option, plus holidays.
  • Sick time as needed.
  • Tuition reimbursement.
  • Team social activities.
  • Employee recognition program.
  • Employee referral program.
  • Paid parental leave and bereavement leave.
  • Incentive programs for senior leadership.
  • Growth opportunities in a fast-paced organization with a people-focused culture.

Saistītās vakances

ASPCA

ASPCA Director of Fleet Safety and Compliance

ASPCA

Lead fleet safety and regulatory compliance for ASPCA programs, mobile clinics, and field operations across the United States. The role oversees driver qualifications, DOT reporting, training, vehicle maintenance, and safety strategy.

Atvērt
LifeStance Health

Head of Clinical Quality and Regulatory at LifeStance Health (Remote, US)

LifeStance Health

Lead clinical quality, patient safety, regulatory readiness, and accreditation across a national mental healthcare provider. Set enterprise standards and guide investigations, governance, and regional improvement.

Atvērt