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Quality Assurance Validation Manager

  • Job type: Permanent
  • Location: Charlotte, North Carolina
  • Salary: Targetted Bonus + Excellent Benefits
  • Job reference: 249381/002_1546638286
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 04/01/2019

Quality Assurance Validation Manager

  • North Carolina

  • Excellent Salary + excellent bonus + excellent benefits

An innovative research-based global pharmaceutical company is seeking a QA Validation Manager to join their growing team at their location in North Carolina! This position was created due the individual getting promoted to a higher-level role in the organization. The company has a rich pipeline of innovative molecules in various phases of development which are targeted in areas of oncology, respiratory and dermatology. They also are a leader in the generics space and impact 100 million patients annually. If you are looking to expand your career in quality with an industry leader that promotes from within than don't hesitate to apply!

The Quality Assurance Validation Manager will have the following responsibilities:

  • Provide leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments, equipment, and facilities) ensuring alignment with corporate standards and regulatory guidance

  • Ensure successful implementation of validation standards as they apply to facilities, utilities, equipment, computer systems, cleaning and processes.

  • Responsible for the support of facility start-up activities, technical transfers, requalifications and routine activities as they pertain to Laboratories, Manufacturing, Maintenance and Warehouse functions.

  • Manage within approved budgets while building best in class quality processes and systems at site.

  • Manage the validation system from a Quality Assurance perspective to ensure quality and compliance requirements are met in an efficient and effective manner, and in support of corporate objectives

  • Act as the quality / validation SME for Change Controls supporting GMP/GLP systems.

  • Ensure required Standard Operating Procedures and systems are implemented to support internal and external validation programs.

  • Quality oversight and approval of software, equipment/facility qualification, IQ/OQ/PQ protocols and reports and associated change control systems.

The ideal candidate will have the following skill set:

  • (8) years' experience in Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, medical device industry (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing.

  • 5 years in Validation

  • Bachelor's degree in Science or Engineering or associated fields (Advanced degrees may be used to reduce ideal experience)

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