Associate Director - RDB4345

JOB DESCRIPTION:

• Provide oversight of investigations, complaints and returns for Allston Operations and Quality (QA/QC)
  
• Guide investigations specialist with aid in establishing the scope of the investigation as well as path forward.
  
• Responsible for site metrics related to investigations, CAPAs, etc. as they relate to Compliance.
  
• Maintain department SOPs consistent with site, industry and regulatory requirements.
  
• Ensuring that site practices are consistent with corporate quality standards as appropriate.
  
• Developing and managing departmental budgets in cooperation with direct staff.
  
• Supporting an environment of staff development and learning. Providing feedback to direct reports in a timely manner.
  
• Managing performance issues and soliciting the appropriate input from HR and management. Writing and administering performance appraisals on time and in a thorough and thoughtful manner.
  
• Developing and executing hiring plans. Ensuring that requisitions are interviewed for and filled in a timely manner.
  
• Keeping senior management apprised of product issues, dispositions and quality improvement plans.
  
• Developing a cohesive team, maintaining and reinforcing a strong quality presence in the manufacturing areas, encouraging positive relationships and networking effectively across sites and organizations
  
• Extensive knowledge of fundamentals in the Biotechnology/Pharmaceutical fields and hands on technical expertise is required.
  
• Comprehensive knowledge of FDA and EMEA regulations of the biopharmaceutical industry, including, but not limited, to aseptic processing of biologics is essential.
  
• Excellent technical writing skills are necessary as well as a working knowledge of statistical analysis, process, software and method validations.
  
• Familiarity with electronic systems including Trackwise, and Catsweb is desirable.

• A minimum 10-15 years experience in a pharmaceutical/biotech GMP environment is required.
  
• Prefer experience in a biologics/aseptic processing facility.
  
• Manufacturing or technical support experience preferred.
  
• Must have prior experience handling operations and QC related investigations and have the ability to coach QA Investigation Specialists.
  
• A college degree in a scientific discipline is required with an advanced degree (MS, MBA or PhD) preferred. Must have demonstrated leadership in an operational/GMP plant setting.
  
• Must be well organized, detail-oriented, and be able to work with minimal supervision.
  
• Outstanding communication skills needed to facilitate and develop relationships with other departments and facilities.
  
• Knowledge of QA/QC and FDA/EMEA requirements essential.