AbbVie

Senior Manager, Pharmacovigilance Quality Assurance

Employer
AbbVie
Location
United States
Posted
Jan 13, 2021
Ref
2009312
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

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 AbbVie plants, affiliates, functional areas and suppliers that provide materials, services and products to AbbVie. This includes API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. Is also responsible for providing support to AbbVie 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 AbbVie 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 AbbVie 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 AbbVie 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 AbbVie 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 AbbVie facilities or those related to suppliers and in the resolution of supplier exceptions to AbbVie 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

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.