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Enterprise Computer System Quality Lead

Richmond, VA | Work from home flexibility

Posted: 04/05/2022 Job Number: JN -042022-14463 Division: Life Sciences

Job Description

Enterprise Computer System (ECS) Quality Lead
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: Enterprise Computer System (ECS) Quality Lead

Location: Client based in Richmond, VA with a facility in Petersburg, VA (one must be at site at either location)
Industry: Pharmaceutical
Hours: Mon-Fri 8AM - 5PM
Salary: Competitive compensation. One s medical benefits (including family) is 100% covered, eligibility up to 30% target bonus (individual and company performance), stock options and 30 days PTO.
Employment Type: Direct hire
Environment: Join a growing pharmaceutical manufacturing company dedicated to providing high-quality, low-cost pharmaceuticals through state-of-the-art, U.S. based advanced manufacturing processes. The company will manufacture precursor chemical ingredients, active pharmaceutical ingredients (API), and finished pharmaceutical products, domestically for essential medicines critical to the ones healthcare.


Role:
The ESC Quality Lead is responsible for defining, planning, managing and implementing supporting documentation, and having quality oversight of the operation of our Enterprise Computer Systems (ECS). This role serves as the system owner for quality tools and technologies and develops processes to ensure that computer systems are in compliance with applicable cGXP requirements, in a fast-paced environment. This individual collaborates with cross-functional teams and external partners to bring excellence in quality oversight and operational execution to all electronic systems.

Responsibilities:
  • Work closely and partner with the internal and external resources and has accountability for our co interest in the quality and compliance aspect of these partnerships. Update management regarding status of deliverables and identify critical activities/risks.
  • Manage system implementations of IT software as assigned including eDMS, LMS, eQMS. Serve as the subject matter expert for implementation, training and ongoing system administration of these systems.
  • Manage vendors in support of quality system implementation.
  • Contribute to the creation and implementation of quality operations strategies for assigned projects and programs.
  • Responsible for calculating and compiling Key Performance Indicators and communicating any trends to management on a monthly basis.
  • Ensure that appropriate compliance activities are maintained during operation to support cGMP compliance (calibration, validation, environmental monitoring) as needed.
  • Ensure the company is prepared for all compliance inspections and support the on site inspections as required.
  • Support supplier/vendor qualification audit and inspection management as needed.
  • Support any customer/vendor compliance audit/inspections as required as needed.
  • Contribute to the review of regulatory authority submission documents, and ensure the submissions are complete and comply with applicable regulatory requirements.
  • Assist in tracking quality commitments and change control activities to ensure manufacturing changes are supported in accordance with regulatory requirements
Qualifications:
  • Understanding of GxP Regulations and Regulatory requirements required for Pharmaceutical productions, Active Pharmaceutical Ingredients.
  • Understanding of System Development Life Cycle concepts and software (e.g., GAMP5 expected pharmaceutical standards, 21 CFR Part 11, Annex 11)
  • Must have system implementation experience preferably Veeva or SAP. Experience with system automation and integration a big plus.
  • Understanding of quality systems implementation including document management, CAPA, deviation, Change Control and training.
  • Experience in implementing enterprise level applications including process automation and system integration.
  • Must be proficient in MS Sharepoint, MS Office 360 (MS Word, MS Excel, MS Powerpoint), Adobe Acrobat Pro.
  • Demonstrated organizational skills, strong verbal and written communication skills, attention to detail
  • Experience developing business processes, Standard Operating Procedures, and Work Instructions preferred
  • Ability to work in a cross-functional team environment with changing timelines and priorities required.
  • Ability to travel to support supplier/vendor relationships and audit programs.
Requirements:
  • Bachelor's degree in related Life Sciences discipline.
  • 15+ years of relevant experience in GxP, Quality Operations positions in a Biotech or Pharmaceutical industry
ADA/EOE

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