Lead Quality/GxP Auditor - 4722

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

Lead Quality/GxP Auditor Responsibilities:

• Identify, analyze, and determine solutions regarding capability gaps
• Partner with the business to define what a qualified RTP team member looks like based on their job responsibilities – then design an appropriate curriculum
• Create, revise, and implement training and related documents, ensuring they are well written, executable, and compliant with applicable policies/procedures
• Facilitate the review of documents and training materials to ensure compliance and learning requirements are met
• Ensure that training solutions are aligned to global strategy where appropriate by proactively connecting with the Global L&D organization
• Ensure that current training courses/interventions are effective – and if not, identify an alternative and implement
• Proactively identify areas where capability challenges exist and design interventions on how to reduce those issues
• Define ongoing ownership and maintenance plan for L&D interventions
• Monitor learning budget for projects within assigned business area/function as applicable
• Create initial project scope documents, appropriately leveraging learning services suppliers for outsourced work to achieve business objectives
• Create, review and oversee execution of implementation plan(s), ensuring effective coordination with personnel who create and revise business area/function SOPs and other documents
• Monitor and communicate program/portfolio status to key business partners
• Anticipate and resolve project/program issues, escalating as appropriate
• Oversee portfolio of projects to ensure on-time, on-budget creation of deliverables that meet quality standards, follow instructional design principles, are approved by appropriate personnel, and meet needs of business (including translations and any “Corporate Initiative” requirements)
• Drive quality standards through review of project documents, design, deliverables, final learning content and evaluation data
• Think strategically about the best way to train our team members – not just what has been done, but the best way to get them effectively trained and able to use their knowledge quickly
• Benchmark cross functionally within Lilly as appropriate, seeking sharing and replication opportunities
• Establish strong relationship with suppliers and Lilly supplier management contacts to align on portfolio of projects and services and ensure seamless quality of deliverables
• Conduct usability testing as required
• Share business metrics, interpretations, and solutions with Supervisor, business partners/process team
• Participate regularly in area/function project and process teams.
• Understand RTP functions deeply, including business goals, job titles and descriptions, key duties, and responsibilities
• Monitor RTP team members’ satisfaction of learning programs and use that feedback to improve our programs
• Consult across the assigned business area/function and the Lilly learning community to ensure training plans align with business plan, strategic direction, and compliance and ethics
• Influence your RTP team leaders to think about the most efficient and effective way to deliver training interventions that are meaningful, useful, and relevant to their roles
• Manage suppliers working on L&D related projects to ensure delivery and performance mirrors or exceeds our agreements; ensure that the deliverables meet the needs of our site team members

Requirements

• B.S./B.A. in scientific discipline as a minimum
• Minimum 3 years of GxP auditing experience in related industry
• Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry
• Experience working in a GxP (regulated) environment.
• Experience in technical writing
• Demonstrated program/project management skills
• Experience with learning & development business processes
• Demonstrated ability to establish strong business relationships
• Demonstrated ability in communication, conflict resolution, and judgment and managing complexity
• Working knowledge of business area/function
• Experienced in Vendor management
• Ability and willingness to challenge business partners regarding ways to use learning interventions to most effectively meet business requirements
• Ability to work independently and in a team environment.
• Strong start-up mindset – think deliver execute review cycle
• Strategic operator – think of where we need to go, but also the tactical ways to get there

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 - $165,000

*Verista is an equal opportunity employer.