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Quality Assurance Manager

2 months ago

Alachua, United States EPM Scientific Full time

EPM Scientific are looking for a top tier talent to join the quality team of one of our clients as a Quality Assurance Validation Manager. The QA Validation Manager will be responsible for overseeing the validation activities of all equipment, processes, and systems to ensure compliance with regulatory requirements and industry standards. This role is critical to ensuring that our products meet the highest quality standards and are safe and effective for their intended use.


Underneath is a description of the duties and responsibilities ideal candidates will have experience with and be able to fulfil.


Mission As the Quality Assurance Validation Manager, you will play a pivotal role in ensuring the highest standards of quality and compliance. You will review and oversee Commissioning, Qualification, and Validation (CQV) and Computer Software Validation (CSV) documentation for Quality Control (QC) and Manufacturing (Mfg.) equipment, Computerized Systems, Utilities, and Facilities using GAMP 5 methodology. Your expertise in regulated environments will ensure our operations maintain rigorous validation standards, meeting both quality and business objectives efficiently.

Key Responsibilities

  • Provide quality oversight for validation activities across manufacturing, facilities, utilities, and QC equipment
  • Define and align methodologies and deliverables for commissioning, equipment IOQPQ, process/analytical validation, material evaluation, utilities, facilities commissioning, qualification, computer system validation, and risk management
  • Review and approve all validation-related documents including Master Plans, Functional Requirements Specifications, User Requirement Specifications, Installation and Operational Qualifications, Validation Protocols, scripts, and reports
  • Author site master files and lead deviation investigations related to equipment and facilities
  • Continually evaluate and improve internal processes to enhance efficiency and compliance with regulatory standards
  • Provide training and guidance on CQV topics to foster a quality-focused culture
  • Act as the subject matter expert in CQV and process owner for the Change Control system
  • Partner with the Validation team to define strategies and implement process improvements
  • Ensure compliance with Data Integrity (DI) and 21 CFR Part 11 Assessments
  • Support pre- and post-execution approval of protocols for new constructions and expansions
  • Monitor quality performance through key performance indicators and present data in meetings
  • Assist in regulatory inspections and client audits, ensuring compliance with cGMP regulations


Requirements

  • Bachelor's degree in any discipline, engineering preferred
  • Extensive experience reviewing and approving commissioning and qualification documentation
  • Background in gene therapy, rare diseases, and neuromuscular diseases is a plus
  • Minimum of 8+ years of industry experience, with 10+ years preferred, focusing on Quality Assurance Validation
  • Familiarity with GAMP 5, process control systems, ERP systems, and MES
  • Strong knowledge of risk-based approaches in biotech manufacturing environments
  • Comprehensive understanding of FDA, EMA, local regulations, and industry best practices
  • Proven ability to work in a fast-paced, high-growth environment with strong analytical and communication skills
  • Excellent attention to detail, project and time management skills, and proficiency in MS Office products and validation software


Benefits

  • Annual bonus
  • 401k
  • Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
  • 20 days PTO
  • 5 days Sick leave
  • 6 weeks Parental Leave


Next Step:

If interested, please email me back with affirmation and any relevant resumes and references

Kind Regards

Marcel