QuVa Pharma

IT CSV Manager

QuVa Pharma • $100K — $130K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in information technology or related field
  • 5-7 years of experience in computer system validation and quality practices
  • Strong understanding of CFR Part 11 and Annex 11 regulations
  • Ability to collaborate with Corporate Quality Assurance
  • Experience in training users on validation processes
  • Project planning and scheduling experience
  • Authorized to work in the US

Responsibilities

  • Develop Computer System Validation strategy for GxP IT systems
  • Collaborate with Quality Assurance to implement and execute validation processes
  • Create Standard Operating Procedures for system lifecycle and risk management
  • Partner with System Owners to maintain validated state of GxP systems
  • Manage validation processes for IT GxP systems
  • Oversee change control processes for IT GxP systems
  • Represent IT during audits and inspections

Benefits

  • Set, full-time work schedule
  • Comprehensive health and wellness benefits
  • 401k retirement program with company match
  • 22 paid vacation days plus 8 paid holidays
  • Occasional overtime opportunities
  • Career advancement opportunities in a high-growth company
Full Job Description
Our IT CSV Manager (Computer Systems Validation) (IT-CSV), plays a vital role within our organization. Once you complete our training, this role will be responsible for the strategy and implementation of the IT Computer System Validation and Quality Assurance program for GxP-regulated IT systems. This individual will oversee the validation and continued compliance of the IT systems and processes. Additionally, this individual will be responsible for the IT GxP Training program.

What the IT CSV Manager Does Each Day:

  • Develops the Computer System Validation strategy for IT systems supporting GxP business processes throughout the complete system lifecycle
  • Collaborates with the Corporate/Clinical Quality Assurance in the development, implementation and execution of CSV process and procedures
  • Develops Standard Operating Procedures and Work Instructions for the complete system lifecycle, including Risk Management, Computer System Validation, and Change Control
  • Partners with System/Process Owners to implement and maintain GxP computerized systems in a validated state and in accordance with regulatory agency regulations and internal requirements
  • Manages and oversees validation of IT GxP systems
  • Manages the change control process across all the IT GxP systems
  • Collaborates with Corporate QA for IT system vendor audit and qualification
  • Represents IT during internal and external agency audits and inspections
  • Develops IT CSV Training program and manages compliance of the training program for applicable IT team members


Our Most Successful IT CSV Manager:

  • Has a sense of urgency, accountability, and resourcefulness (e.g., work in a changing environment)
  • Is a self-starter and independent learner
  • Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
  • Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform
  • Has natural curiosity to take on new challenges, responsibilities, and gain business knowledge


Minimum Requirements for this Role:

  • Bachelor's degree in information technology, or related field, required
  • 5 -7 years of experience in developing and implementing computer system validation, data integrity, and quality practices; Experience with computer system validation across manufacturing operations, ERP systems, Quality Lab systems
  • Excellent understanding of the CFR Part 11 and Annex 11 regulations for computer systems
  • Collaborative skills in working with a wide range of users including Corporate Quality Assurance to develop Computer System Validation program
  • Experience with educating and training users at different levels on the computer system validation process and practices
  • Experience with planning and scheduling the timely completion of system validation projects
  • 18+ years of age
  • Able to successfully complete a drug and background check
  • Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas


Benefits of Working at Quva:

  • Set, full-time, consistent work schedule
  • Comprehensive health and wellness benefits including medical, dental and vision
  • 401k retirement program with company match
  • 22 paid days off plus 8 paid holidays per year
  • Occasional weekend and overtime opportunities with advance notice
  • National, industry-leading high growth company with future career advancement opportunities


About QuVa Pharma

QuVa Pharma is a pharmaceutical company that specializes in the production and distribution of sterile injectable drugs. The company's products are used in hospitals, clinics, and other healthcare facilities to treat a variety of conditions, including pain, infections, and cancer. QuVa Pharma's facilities are located in Texas and North Carolina, and the company has distribution centers throughout the United States. The company was founded in 2015 and is headquartered in Sugar Land, Texas.
Learn more about QuVa Pharma
Size
500 employees
Industry
Pharmaceuticals & Biotech
Founded
2015
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at QuVa Pharma

More Pharmaceuticals & Biotech Jobs

Find similar IT CSV Manager jobs:

NationwideRemote