Skip to main content

Search jobs

Search jobs

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.

Manager, QA

Campbell, California Req ID 2210235 Category Quality Assurance Division AbbVie
  • Manage GxP inspection activities to assure that R&D quality system, manufacturing facilities, testing programs, clinical and pre-clinical study conduct, personnel and records in support of worldwide regulatory filings are able to demonstrate compliance to policies, procedures and applicable government regulations.
  • Influence and train inspection preparation teams comprised of a variety of technical experts.
  • Coordinate GxP pre-approval inspection preparation activities for contract facilities utilized in support of regulatory filings.
  • Strategize corrective action plans and provide compliance support during implementation to ensure successful inspections.
  • Effectively communicate risks to management, both orally and in writing.
  • Quality Systems: Provide guidance and interpretation of Affiliate QA Policies and Procedures based on applicable requirements/regulations
  • Management of the global AbbVie R&D self-inspection program including organization of the global, internal audit schedule

  • Bachelor’s degree, preferably in physical science (e.g. Chemistry) life science (e.g. microbiology or biology) or pharmacy. Strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized technical fields.
  • Accreditation by a professional body desirable. Examples include American Society for Quality (ASQ) Certified Quality Manager (CQM) or Project Management Professional (PMP Certification.
  • Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory or Validation background in a regulated industry required. Experience in two or more of the following areas: Clinical Operations, Pharmacovigilance, manufacturing/testing of sterile dosage forms, biologics, liquids, solid dosages, active pharmaceutical ingredients or medical devices.
  • Thorough, documented understanding/knowledge of international GXP regulations. Knowledge of pharmaceutical drug development and clinical research processes.
  • Regulatory inspection experience preferably with direct agency inspector interaction.
  • Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
  • Strong project management skills are essential.
  • Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
  • Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make difficult decisions, often at short notice.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Quality Assurance, Campbell, California, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation