Lead Quality/Gxp Auditor - 4722

Verista’s600 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
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.