Associate Director Quality and Validation

10/11/22

Boston, MA

1829

Senior Quality Associate III

Our client is seeking a highly motivated and experienced individual for the position of Senior Quality Associate III. This position will report to the Director, of Quality Assurance Development and External.

Responsibilities:

  • Champions GMP requirements in both routine and non-routine operations.
  • In conjunction with the SME write deviations and change control, CAPA’s and associated quality record.
  • Deviation review and approval, issue resolution and CAPA monitoring.
  • Perform batch review and approval according to company procedures and ensuring compliance to GMP standards.
  • QA lead for risk assessment and root cause analysis as required.
  • Monitor and evaluation of on time closure of records. KPI data - monitor and evaluate trends, propose CAPAs to eliminate adverse trends
  • Provide quality oversight at CMO to ensure compliance with the requirements of the quality agreement.
  • Perform quality record /document review and approval according to company procedures and ensuring compliance to GMP standards.
  • Co-ordinate PQR generation as required.
  • Serve as Quality Assurance support and SME for Drug Substance/Drug product manufacture maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing storage and shipping activities are compliant.
  • Accountable for the on-time disposition of clinical/commercial products in line with the agreed schedule
  • Support all PPQ process and product related activities for drug substance e.g. process characterization, cleaning validation, process validation (including e.g. stability studies, hold time studies, review and approval of protocols). Review and approval of associated documents.
  • Ensure compliance of quality systems other applicable regulations/standards and internal procedures. Support implementing improvements at the CMO in deviation and changer control systems.
  • Provide the requisite quality support to the regulatory/CMC group in support of license applications
  • Keep up to date with FDA/EU regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance for product commercialization.
  • Build strong effective working relations with CMO’s from a quality and compliance prospective.
  • Proactively support regulatory inspections at the CMO sites that may impact compliance status or require regulatory notifications.
  • Participate in internal and external audits as required.
  • QA lead for root cause analysis and risk assessment activities as required.

Skills:

  • Show strong negotiation skills
  • Demonstrated ability to priorities work to act and work independently
  • Has a strong broad GMP and technical know how to handle emerging issues
  • Excellent verbal and written skills
  • Strong understanding of Pharmaceutical Regulation in own area and department
  • Competent in the use of electronic systems to support own role and departmental requirements.
  • Competent in application of data integrity requirements.
  • Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
  • Can get things done based on influence.
  • Comfortable working in a fast-paced environment with multiple issues open simultaneously.
  • Customer service mindset
  • Identifies opportunities to improve and contributes to problem solving.

Education:

  • BS in scientific discipline or equivalent.
  • 5 years’ experience in quality in the pharmaceutical industry; preferably in biologics/ sterile manufacturing
  • Prefer specific education or certification in adult learning and/or quality management.
  • Experience in CMO operations preferred
  • Ability to interact effectively with health authorities

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