General Summary:

Provides guidance to QA, QC, Production and Clinical personnel on details of GMPs and compliance. Oversees the disposition of raw materials and final product, and oversees the investigations of process excursions (CAPA). Responsible for the scientific evaluation of data in regards to release/rejection of GMP Cleanrooms, Utility Systems, Raw Materials, In-Process Intermediates and Final Product in accordance with CBER standards.

• Oversees the QA department including Document Control, Compliance, Training and Lot Release. Uses scientific logic and practical application of FDA compliance guidelines in addressing unique challenges presented by Clinical and Commercial biological patient-specific products.
• Responsible for the overall development of a functional and effective Quality Assurance program in preparation for commercialization and Pre-Licensing Inspections. This includes development of key Quality systems to ensure a solid foundation and compliance with State and Federal regulations.
• Provide leadership to QA staff of 10(+). Organizes department to meet monthly objectives, and develops organizational structure for eventual commercialization of product. Generates and maintains annual budget.    

Primary Responsibilities:

Management:
Develops and reviews department budget.  Identifies areas of improvement and resource allocation.  Develops monthly goals for subordinates.  Mentors staff in application of GMPs and career growth. Provides conflict resolution, manages annual Performance Reviews. 

• Provides general and direct supervision to Lot Release, Compliance and Documentation staff. Performs annual performance reviews. Manages and motivates QA staff. Mentors staff in compliance and career development.

• Communicates effectively with senior management, peer department heads, and general GMP personnel, which requires strong oral and written communication skills. Variety of departmental peers includes molecular biologists, cell culturists, biochemists, engineers, aseptic operations management, quality control, finance and regulatory affairs.

• Develops organizational structure of department. Develops and manages department budget. Identifies resource allocation and effectively communicates departmental needs.

Batch Record Disposition:

• On-going issuance, review and disposition of batch records. Manages filing system for Batch Records. Performs Quality Assurance review of manufacturing process and testing. Gives disposition for release of product.

Document Control:

• Provides guidance to Document Control department. Oversees Change Control Program. Writes and/or reviews SOPs, Controlled Forms, Specifications, Test Methods, and Batch Records for GMP and GCP operations. Responsible for all related document control functions.

• Ensure that all deviations, OOS, OOT, investigations, and NCMRs are reviewed and that corrective actions are completed. Provides guidance to Production in performing investigations.

Raw Materials:

• Oversees Raw material disposition and on-going review of controlled materials. Gives disposition for release of raw materials for manufacturing process and testing. Manages Disposition label system.

• Oversees the internal and external auditing functions. Generates and Reviews auditing reports. Manages regulatory inspections. Generates annual product review.

• Provides strong, interactive presentations to individuals, department, corporate partners and company on topics of compliance, FDA inspections, quality initiatives and milestone projects.

Qualifications:

• Bachelor's Degree in a Life Science.
• Minimum of 8+ years direct experience supervising a cGMP Quality Assurance department in a biotechnology (CBER regulated) commercial company
• An array of computer skills, such as knowledge of the MS Office Suite (Word, Excel, Powerpoint, Access, etc.), intranet, and the internet. CAMSTAR, SCORE or Documentum a plus.
• Knowledgeable in all aspects of GMPs/regulations for biotechnology products.
• Ability to manage meetings in an effective manner.
• Ability to speak effectively to large groups
• Ability to train, mentor and manage others at all levels
• Ability to set standards and provide guidance on delegated tasks
• Knowledge of different types of FDA inspections
• Knowledge of corporate and vendor audits
• Ability to interact with FDA and auditors
• Ability to manage multiple systems

Send CV by e-mail to: hr@favrille.com or by fax at 858-597-7040.

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