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Quality Assurance Validation Specialist
Cambridge, MA  Posted: 6/6/2019


Lead Specialist, Quality Assurance Validation- Drug Product 
Join our clients enthusiastic and collaborative Quality Assurance Validation (QAV) - Drug Product team to contribute to the overall success of our novel gene therapy.  This position will support the organization through the establishment of validation/qualification programs across disciplines and ensure alignment with industry standards in accordance with the relevant product’s lifecycle. In this position you will be responsible for guidance and technical review of protocols and reports related to test methods, technology transfers, process characterization, and process validation activities. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects.  The successful individual will own, lead or support multidisciplinary, multi-site, moderate to complex projects.

About the role:
  • Provide support and guidance for the development, execution, data analysis and reporting of external clinical and commercial protocols as necessary.
  • Provide support and guidance in the development and execution of CxO validation / qualification documentation.
  • Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
  • Ability to multitask and prioritize independently in a high paced environment.
  • Thorough knowledge and understanding of FDA and foreign requirements and expectations.
  • Provide Quality Assurance Validation support to CMC and Tech Transfer teams.
  • 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.
  • 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.
About You:
  • Wide range of expertise or working knowledge across validation disciplines including process validation, method validation, and cleaning validation.
  • Expertise in support of Tech Transfer initiatives.
  • Bachelors’ and/or Masters’ degree in Engineering, Biochemistry or related field required.
  • Technical understanding of biopharmaceutical production. Expertise in best practices for aseptic processing and contamination control
  • A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
  • Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
  • Leadership skills to lead cross functional teams to ensure project success.
  • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
  • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
  • Ability to travel approximately 25%
  • Experience within a multi-product facility and/or Contract Manufacturing Business 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.

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