Quality Lead/ Lead Validation Engineer - 5122

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

Quality Lead Responsibilities:

This position will be responsible for supporting the QISM group at the Client, specifically focused on IT Infrastructure and the Clinical Operations areas. This position will be working closely with the operational functions, DTE (IT), and other GxP QA groups to provide oversight of computerized system implementation, maintenance, and retirement used in these areas. This role will review and approve computerized system lifecycle documentation as well as provide Part 11/ Annex 11, and data integrity expertise to key stakeholders internal to the Client.

• Has understanding of regulations pertaining to the implementation and use of computerized systems in all GxP areas

• Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5

• Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas

• Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity

• Identifies and escalates areas of risk or non-compliance to manager / leadership team

• Participates in performing Periodic Review activities of Computerized Systems

• Provide support to regulatory inspection preparedness activities as needed

Requirements

MINIMUM QUALIFICATIONS:

• Experience performing Infrastructure Qualification activities

• Bachelor's degree and relevant GxP work experience

• Proficiency in using Microsoft Office applications

• 8-10 experience performing validation activities.

PREFERRED QUALIFICATIONS:

Experience with the following:

• Performing Quality Assurance function related to Clinical Computerized Systems / Infrastructure

• Proficiency with regulations related to FDA / MHRA regulations

• Use of computerized quality management systems

• Experience with validation of Enterprise / Lab Computerized Systems

• Quality metrics, dashboards, analysis and improvement programs

• Knowledge of GAMP and Agile validation lifecycle and methodologies

• Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization

• Proven attention to detail and organization in project work

• Capable of working on assigned tasks without mentorship

• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including:

• Good Documentation Practice (GDP) in pharmaceutical environment

• 21 CFR Part 11

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.

$87,780-140,220

*Verista is an equal opportunity employer.