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Remote Senior Manager Quality Assurance

  • Chicago, IL
  • Direct Hire
  • Job ID: BN38-2691860

$1 to $2 Per Year

The Senior Manager, Pharmacovigilance Quality Assurance provides leadership, direction and perform evaluations for compliance with US and foreign regulation requirements and provide relevant and constructive evaluation of quality related systems for Company plants, affiliates, functional areas and suppliers that provide materials, services and products to Company. This includes API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. Is also responsible for providing support to Company plants in the resolution of regulatory issues and issues related to suppliers. Their leadership, direction and execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with Company policies/procedures and applicable quality and regulatory requirements to assure the quality, effectiveness and safety of our products.
  • Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Company specifications.
  • Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
  • The major responsibilities of this position are primarily focused on Company facilities and key suppliers whose processes are more complex, comprehensive and critical to the business.
  • Lead or participating in more technically complex and strategic projects.
  • The position serves a tactical purpose for Company and must achieve a difficult balance of involvement, independence and objectivity.
  • Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.
  • Collaborate with internal operations on quality issues at Company facilities or those related to suppliers and in the resolution of supplier exceptions to Company specifications. Auditing serves to provide feedback in the form of audit observations, formulation of recommendations, review of corrective actions and to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
  • The position also provides an active role within the corporation as experts in GMP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.


Qualifications

 

  • Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience at least 8 years) with exposure to medicinal or combination product related industries.
  • Knowledge and thorough understanding of global Pharmacovigilance regulatory requirements and industry best practices and an understanding of the principles of quality management.
  • Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
  • Strong analytical skills and the ability to organize work in a logical, through and succinct manner. Project management, interpersonal, and excellent communication skills. Flexibility to adapt to changing assignments and ability to effectively prioritize workload.
  • Persuasive, effective communication skills are essential with an ability to work effectively outside of the company and in cross-functional teams.
  • 10 years of experience in the biopharmaceutical industry or with a regulatory authority, including 6 + years in quality assurance and/or pharmacovigilance. Experience in compliance/auditing is desirable
  • ASQ certification desired

 

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