Senior Quality Engineer- GCLP

Senior Quality Engineer

The Sr. Quality Engineer should be familiar with global Health Authority Regulations including US FDA, ICH and guidelines (GAMP, Computer Systems Used in Clinical Investigations, etc.) and is responsible for the oversight, review, and approval of GCP/GLP/GVP related computer system validation activities with a focus on quality support over GcLP internal validation activities of computerized systems/instruments/equipment, research computer systems vendor audits and internal system audits.

The Manager will also partner with R&D to create a quality culture to provide business support, process improvements and inspection support as needed. This position may interact with regulatory agencies and corporate partners during inspections and audits, and it will require travel for auditing vendors.

• Lead and co-lead internal and vendor computer system audits related to GCP/GLP/GVP systems including but not limited to pre/post audit meeting, agenda, partnering with key stakeholders, review of legal contracts and vendor/internal processes ensuring systems are developed, validated, managed, and controlled based on applicable regulations and guidelines.
• Manage audit related observations and CAPAs.
• Work closely with Digital Technology department, system owners and business owners to implement new systems/instruments/equipment effectively and efficiently, system upgrades, or system modifications.
• Participate in the change control program for modifications to qualified systems and/or implementation of new systems.
• Review and approve computerized system, GcLP laboratory instruments, and GcLP equipment related documents and procedures.
• Support regulatory agency inspections as needed.
• Participate and actively engage in strategic initiatives which require CSV support.
• Provide support and input into the full CSV and SDLC program.
• Contribute to the continuing development of a quality culture
• Perform other tasks as assigned by line manager.

• BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience in pharmaceutical / biotech industry with experience in the R&D Computer Systems Validation GCP/GLP/GVP environment.
• Demonstrated ability to work in a risk-based CSV environment following the associated regulatory expectations.
• Knowledge of Software Development Life Cycle (SDLC) principals including planning, analysis, design, development, testing, implementation, and maintenance is required.
• Experience and practical understanding of the development and validation of custom GAMP category 5 software, modules, interfaces, and reports is desired.
• Experience and proficiency with CSV audit for Research computerized systems is desired.
• Practical understanding of GAMP and ERES standards and guidance.
• Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations (understanding of regulatory guidelines for other countries a plus), CFR 21 Part 11.
• Expertise with business office applications, word processing and spreadsheets.
• Demonstrated knowledge and/or prior experience in Quality Assurance and oversight of GVP systems such as Argus and Signal Detection.
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.
• Relies on experience and judgment to plan and accomplish goals.
• Excellent organizational skills and keen attention to detail.

• Travel up to 30% based on business need.