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Lead Specialist, QA Validation

Company: Resilience
Location: Durham
Posted on: January 25, 2023

Job Description:

Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients' lives.For more information, visit .Position Summary & RoleThe Lead Specialist, QA Validation is a member of Resilience RTP enthusiastic and collaborative Quality Assurance Validation (QAV) team and contributes to the overall success of our novel gene therapy. The focus of this position is to support the organization through the establishment of Resilience validation/qualification programs across disciplines and ensure alignment with regulatory requirements and industry standards in accordance with the relevant product's lifecycle. This position is responsible for guidance and technical review of protocols and reports related to equipment, facilities, computer systems, technology transfers, test methods, cleaning, process validation, cold chain storage and shipping validation activities. These activities will encompass technology transfer and commercial projects. The Lead Specialist, QA Validation will own, lead or support multidisciplinary, multi-site, moderate to complex projects.Job Responsibilities:

  • Provide QA support, input and oversight for the manufacturing site
  • Provide QA support for validation activities including:
    • Process Validation
    • Analytical instrument qualification, use and maintenance
    • Computer systems validation
    • Equipment Utilities, and Facilities commissioning, qualification, use and maintenance
    • Validation of Cleaning, Sterilization, and Decontamination processes
    • Provide guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), protocols, data analysis, and final reports.
    • Ability to drive the implementation of new policies and procedures to support Resilience quality systems.
    • Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
    • Ability to multitask, manage timelines and prioritize independently in a high paced environment.
    • Thorough knowledge and understanding of FDA and foreign requirements and expectations.
    • Works closely with all site functional teams (Manufacturing, Facilities, QC, etc) responsible for protocol development and execution to provide QAV support.
    • Provide support of Resilience internal QC lab along with assay/method development.
    • QA Approval of change controls and validation documents e.g. Impact Assessment, Risk Assessment, Protocol, Report, and User Requirements.
    • Represent the Quality Assurance Validation group in project teams, audits and inspections as required.
    • Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
    • Support the development of long-range goals and objectives.
    • Exercise considerable latitude in determining objectives and approaches to critical assignments.Preferred Experience, Education & Qualifications:
      • Wide range of expertise or working knowledge across validation disciplines outlined above.
      • Expertise in support of Tech Transfer initiatives.
      • Experience with upstream, downstream or fill/finish manufacturing.
      • Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
      • A minimum often (10) years of experience in the industry, ideally all clinical phases through commercial drug product.
      • Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, QlO and other international regulatory requirements relevant for process, cleaning and equipment validation.
      • Knowledgeable of Data Integrity requirements.
      • Leadership skills to lead cross functional teams to ensure project success.
      • Excellent written and verbal communication skills including the ability to communicate, influence and negotiate across the organization.
      • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
      • Ability to travel approximately 5-10% based on project demand.
      • Experience within a multi-product facility is a plus.
      • Experience using risk-based approaches (FMEA, PHA, etc).
      • Project management experience.
      • Strong analytical ability.
      • Experience supporting internal regulatory and partner inspections.
      • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
      • Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $115,000.00 - $145,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Keywords: Resilience, Durham , Lead Specialist, QA Validation, Other , Durham, North Carolina

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