Senior Manager - Computer Systems Validation

Urgently hiring Senior Manager of Computer Systems Validation Engineer for Biotech Research Company

  • Waltham, MA
  • $150,000 - $170,000
Easy Apply Now

A bit about us:

We are accelerating personalized medicine research by empowering patients with their healthcare data and making it as easy as possible for them to participate in the medical research process. We partner with patients and pharmaceutical companies to accelerate precision medicine R&D by securely and efficiently collecting and providing patient samples and relevant health data. We partnered with 20 of the top 40 global pharmaceutical and biotechnology companies to help increase the speed and quality at which they are conducting their research. For the past two years, we received the prestigious designation as a “Great Places to Work” company. It is an exciting time; our biotech company is growing quickly and needs the best team members to join us.

Why join us?

  • Competitive compensation
  • M/D/V
  • Bonus
  • Fully remote

Job Details

About the Role:

The Senior Manager, Systems Validation Engineer will be responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Clinical Practices (GCP), and all other regulatory requirements including GAMP5.

Qualification/Validation of Internal, External Technologies and Processes

  • Responsible for conducting and completing the review of company practices associated with clinical systems validation (CSV) requirements.
  • Execute system validation IQ/OQ/PQ protocols, test plans, and change controls according to approved procedures.
  • Compile validation packets, prepares reports and makes approvals or recommendations for changes and/or improvements.
  • Author SOPs.
  • Author, review and/or approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
  • Maintain all documentation pertaining to qualification/validation.
  • Oversee the execution of qualification/validation activities of new software implementations and maintenance of existing systems.
  • Stay abreast of the latest developments, advances and trends in healthcare and information technology, as well as federal and state legislation to ensure optimal professional effectiveness and competence.

Team & Vendor Management

Grow and develop team structure which includes, but is not limited to:
  • Supervise current team and/or contractors for CSV/IT
  • Hire, contract, and manage additional resources to meet operational needs
  • Project manage the contract personnel through completion of assignments.
  • May provide day-to-day guidance and training to other validation technicians.
  • Serve as an information resource to validation technicians, employees, contractors, and vendors.

Compliance Requirements

  • May also investigate and trouble-shoot problems which occur and determine solutions.
  • Initiate and update GxP and risk assessments with functional teams to assess system risks, develop mitigation plans, and implement.
  • Provide input to GxP assessments for 21 CFR Part 11/Data Integrity requirements.
  • Review and provide responses and feedback to vendor validation documentations.
  • Work closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement.
  • Support inspection readiness programs and/or directly support regulatory agency inspections.
  • Assist in the coordination of a response to any findings, as applicable.
  • Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards, and global regulations.
  • Resolve qualification/validation issues.

Position Requirements

  • Bachelor's degree in Computer/Information Systems, Engineering, Science or equivalent technical discipline.
  • 8-10 years of experience working in biotech/pharmaceutical industry supporting Regulated Products in Quality compliance or Computer System Validation role.
  • 5-7 years experience in IT Systems Validation testing.
  • 5 years experience leading IT teams with personal accountability for decision-making and supervision.
  • Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle (SDLC) of automated computer systems within biopharmaceutical environments.
  • Understanding and application of validation principles, concepts, practices, and standards.
  • Ability to manage multiple small and large projects simultaneously.
  • Strong knowledge in 21 CFR Part 11, GAMP5, electronic record/electronic signature, and data integrity requirements, standards, and guidelines.
  • Strong background and understanding of FDA regulations.
  • Knowledge of Good Clinical practice (GCP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
  • Working knowledge of the software development lifecycle (SDLC).
  • Experience with vendor audits, quality agreements.
  • Expertise in Project Management processes, strategies and methods.

Preferred

  • PMP Certificate or equivalent.
  • Experience representing IT as a SME in regulatory audits.
  • Experience with GDPR, e-Privacy Directives, e-Consent, eCOA and ePRO, BAA, HIPAA & Privacy Rules.
  • Experience with CDR, eTMF, Advanced Data and Analytics tech.
  • Certified Clinical Data Manager - Society for Clinical Data Management (SCDM).
  • Training to aid in system adoption and successful implementation with all user levels.
  • Previous experience having worked in a GCP environment.
  • Advanced Degree in Computer Science, Business Information Systems.
  • Experience in pharmaceutical drug development processes and clinical systems, including CTMS, IRT, EDC, Clinical Data Repositories (CDR) and/or other related technology in the pharmaceutical/biotechnology industry.
  • Working knowledge of validation of process control (PCS) and data acquisition systems.
  • Experience in a high growth start-up environment.

Technology Experiences

  • Salesforce
  • Box
  • Clinical trial Management Systems (CTMS)
  • Electronic signature software, e.g. DocuSign
  • Scheduling software, e.g. Skedulo
  • Lab Information Management Systems (LIMS)
  • Google Suite/MSFT Suite
Easy Apply Now
Easy Apply Now
Job Details
Managed by Jobot Pro
Location
Waltham, MA
Job Type
Permanent
Compensation
$150,000 - $170,000