Principal Quality/GxP Auditor

Verista’s 600 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

Principal Quality/GxP Auditor Responsibilities:

• Develop and present Compliance plans and strategies based on client requirements.
• Actively consult clients on industry best practices and regulations.
• Provide mentorship and training to lesser experienced team members.
• Support inspection readiness audits and large-scale remediation efforts.
• Act as subject matter expert in all areas of Quality & Compliance.
• Guide and ensure client compliance with industry best practices and regulations.
• Review GxP auditing projects for correct approach, consistency, and quality; and identify and incorporate opportunities for improvement.
• Provide coaching and/or training to company peers on quality-related matters and audit execution
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
• Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization.
• Ability to mentor and guide lesser experienced team members.
• Ability to communicate effectively with clients.
• Proven ability to identify areas of business expansion and report to the management team for follow-up.
• Intermediate Microsoft Project capabilities.

Requirements

• Must be willing to travel to potentially multiple client sites including Las Vegas, NV
• Demonstrated delivery of Quality Lead level requirements.
• Demonstrated capability to deliver on the Senior Quality Lead Responsibilities.
• Demonstrated expert knowledge of GxP regulatory requirements and industry best practices.
• Capable of delivering industry lectures and training on applicable experiences.
• Capable of identifying, proposing, and selling services to clients
• Resource must have 10+ years of demonstrated experience in:
  • FDA Law, Policies and Provisions specific to section 503B to the FD&C Act.
  • Current Good Manufacturing Practices - Title 21 CFR Parts 210, 211, 820
  • Execution of Current State GAP Assessment and FMEA activities
  • Developing and driving risk based CAPA Plans & Remediation Efforts
  • Consistently communicating/interacting directly with Health Authorities
• Excellent knowledge of Quality system principles; FDA Quality System Regulations (cGMP); ISO 13485 Quality system standards for medical devices or ISO 9001 Quality Management Systems and IS014971 Risk Management Systems required.
• Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
• Experience and capability of effectively communicating requirements (written and orally) with a rationale to different levels of the client’s organization
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Ability to mentor and guide less experienced team members
• Ability to communicate effectively with clients
• Proven ability to identify areas of business expansion and report to management team for follow-up
• Ability to work independently and as part of a team, with the ability to transition between the two

Benefits

Why Choose Verista?

• 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

For more information about our company, please visit us at Verista.com

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

$85,000 - $173,000

*Verista is an equal opportunity employer.