Job Description Associate Director, Quality Assurance (Batch Disposition)

Role Description:

Reporting directly to the Director of Quality Assurance, the Associate Director, Quality Assurance will be responsible for leading the Quality Assurance Batch Disposition function and collaborate cross-functionally with the CMC group to ensure clinical trial material is manufactured and tested according to GMPs.

Responsibilities:

  • QA interaction with QA contacts at Contract Manufacturing Organizations (CMO)
  • Review and approve Master Batch Records
  • Execute Batch Record reviews and approvals; deviation resolution, and batch disposition (including generation of certificates of release and compliance, etc.)
  • Responsible for adherence with quality agreement provisions
  • Ensure GMP compliance is maintained
  • Work with CMO’s to assess out of specification results, investigations, and deviations and bring to closure in a compliant manner.
  • Ensure timely implementation of corrective actions and escalate as necessary.
  • Ensure products meet regulatory requirements
  • Review and approve CMO change controls as required
  • Review product stability protocols and reports
  • Review analytical method qualification protocols and reports
  • Perform Quality Assurance review and/or document audits on contractor documents
  • Support internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, regulatory guidelines
  • perform and/or review GMP investigations
  • Perform training as needed
  • May perform document change control activities (i.e., SOP writing) as needed
  • May perform External GMP Audits/Vendor Qualifications, risk assessments and write and/or review audit report
  • Provide audit/inspection support and all quality related services as required (e.g. health authority requests for information, providing stability updates, expiry changes, change notifications, batch documentation, etc.)
  • Develop, revise, implement and adhere to Quality Assurance department policies and procedures
  • Assist with maintaining file organization within the Quality department
  • Other duties as assigned

Education/ Skills Required:

  • Bachelor’s or Master’s degree in Life Sciences field or equivalent years’ experience, with 10+ years pharmaceutical industry experience and a minimum of 8 years in Quality Assurance
  • Previous small molecule drug and NDA-level experience are a strong plus
  • Established working knowledge of Good Manufacturing Practices and other applicable regulations (US and international)
  • Quality Assurance experience supporting both development projects and commercial products.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator
  • Strong communication skills both written and oral
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Professional demeanor and an excellent written and verbal communicator
  • Detail oriented and well organized
  • Good and thoughtful listener
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications