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

Requirements

Quality Assurance IT Automation Responsibilities:

• The Quality and Regulatory family of roles is involved at every step in the product lifecycle chain. The primary responsibilities of this job family is to provide guidance, assess current state and execute project deliverables based upon experience, client requirements and a comprehensive understanding of federal regulatory requirements and ICH (International Council for Harmonization) guidance. The roles within this job family will work to identify, address, and mitigate regulatory & compliance issues for clients. These individuals will assist clients to return or reach conformity through the implementation and/or enhancement of the site’s Quality Management System (QMS) while ensuring conformance to FDA and international regulations and standards. The roles within this job family may work in concert with the client or as part of a Verista team and will ensure deliverables are accurately prepared to meet internal and external quality standards, are accurately presented, and efficiently closed out.
• Lead/Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
• Review audit and assessment reports and ensure audits are performed to a high degree of client satisfaction and within the budgeted time.
• Review assessment finding reports and action plans to ensure compliance.
• Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• Enterfacing with MMD IT and other internal & external entities to align GMP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.
• Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
• Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.

You will have:

Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.

Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.

Min 5 years of experience in regulated pharmaceutical manufacturing industry.

At least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.

Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.

Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.

Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.

If you are qualified, have leadership potential and a willingness to learn, Verista could be the right career choice for you!

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.
• 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 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.

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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