Lead 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

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.