Quality Manager

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• The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance Vaccines and will review and approve validation related studies for assigned areas.
• These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.
• This position has signatory responsibilities for validation/qualification documents within assigned areas.
• Candidates should have some knowledge in biotech manufacturing processes (i.e., viral antigen production).
• Excellent communication skills and teamwork are a must, as individual will be working on cross-functional project teams which include members from various organizations within Company such as Manufacturing Technology, Engineering and Regulatory Affairs.
• Good interpersonal and influencing skills are important for a candidate's success in this role.

• Master's degree in engineering, Science, or related field with 5+ years' experience preferably in a cGMP environment.
• Strong knowledge of cGMP regulations and quality standards applicable to pharmaceutical manufacturing, in particular VACCINES.
• Proficient in relevant computer systems and software used in validation and quality management (e.g., LIMS, Track Wise, SAP).
• Ability to effectively communicate technical information to diverse stakeholders, including technical and non-technical audiences.
• Strong working knowledge of Quality System Regulations.
• Experience leading CAPA (Corrective and Preventive Action) activities.
• Ability to handle multiple projects concurrently.
• Well-developed communication skills, both verbal and written.
• Years of
  
  Experience:
  
  7+Years.

• Mid-Senior level

• Contract

• Quality Assurance

• Pharmaceutical Manufacturing

Nazareth, PA $95,330.00-$ 1 month ago