Director of Quality Assurance - Biotech

Posted 08 March 2023
Salary Negotiable
LocationMassachusetts
Job type Full Time
Discipline Life Science Consulting
Contact NameChristian Lee

Job description

​​Mantell Associates are currently partnered with one of the most exciting Biotech organisations who are searching for a Director of Quality Assurance.

Director of Quality Assurance - Responsibilities:

  • Interact with customers and potential customers as required regarding products, specifications, and returned products

  • Act as the top enforcer for cGMP compliance across departments

  • Prepare all regulatory submissions such as Drug Master Files, Annual DMF Updates, CMC sections, DEA permits and updates

  • Back up for all direct report functions

  • Act as the primary contact for all regulatory audits including FDA inspections and DEA audits 

  • Prepare goals for the group on an annual basis

  • Supervise and guide internal audits of various departments/processes

  • Oversee and perform QA Document Control activities including processing of change requests, manufacturing records, and other documents

  • Assist the development of strategic plans and be at the forefront of ensuring development of staff at all levels

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Director of Quality Assurance - Requirements:

  • Bachelor of Science preferred, in a scientific/technical discipline with experience in a quality leadership position within the biological and/or pharmaceutical industry

  • Knowledge of Standard Operating Procedures (SOPs), including but not limited to assay and testing procedures, and current Good Manufacturing Practices (cGMPs)

  • Significant experience in supporting functional areas (e.g. PD, Manufacturing, QA, Engineering, EHS) preferred

  • Experience with writing Deviations, Lab investigations and OOS 

  • Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities

  • Must be able to assess and utilise software and custom programs to meet QC business needs

  • Excellent team player with good communication, analytical and problem solving skills; knowledge of process research and laboratory practices

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Christian Lee on +44 (0)20 3854 7700 or christian.lee@mantellassociates.com.