Senior Quality GxP Auditor Lead - 3313BC

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

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

This position is remote !

Requirements

• Activities: Phase I will include a remote review to evaluate the current state of process flows requiring documentation for the site. This evaluation will include, but not be limited to the following:
• o Assess current company documentation established for site and gather templates.
• o Meet with stakeholder(s) and identify documentation required for inclusion in the project plan.
• o Identify and assess process flows currently generated.
o After review, focused workshops between company Stakeholders and Verista SMEs to discuss current state documentation and goals for future state programs to ensure compliance.

Deliverables:

o CMC Documentation Project Plan & Tracker

§ Verista to provide Project Plan & Timeline based upon the artifact review and stakeholder meetings.

1.2 Phase 2 – Development & Delivery of CMC/Quality Artifacts

Activities: Phase II will include the development and delivery of the documents initiated within the CMC Documentation Project Plan during Phase I. The activities will include, but not be limited to, the following:

o Project Management by Verista
 Maintenance of the CMC Documentation Project Plan & Tracker
 Assignment/tracking of deliverables of the Verista team
 Tracking documents through the review and comment cycle and coordinating review workshops with stakeholders for specific documents if required.
 Submission of weekly status updates to Project Team.
 Inclusion of documents and readjustment of project plan as requested by Company.
o CMC & Quality Documentation Development & Delivery
 Development of CMC/Quality Documents:
o Drafting of new CMC/Quality documents from process flows generated by or with the Company stakeholders per the Project Plan

Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical premiums for Employee option.
• Company paid Life, Short-Term, and Long-Term Disability insurances
• Dental & Vision insurances
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• Leadership development training, career planning, and tuition reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Maternity, Parental Leave and Bereavement

Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing, and distribution. This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.

For more information about our company, please visit us at Verista.com or follow us on LinkedIn.

*Verista is an equal-opportunity employer.

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