Quality Assurance Senior Manager - job 1 of 2

As a Quality Assurance Senior Manager at AbbVie, your main responsibilities will include managing daily activities of the Quality staff, ensuring compliance with cGMP regulations, overseeing drug product manufacturing and batch releases, supporting audits, and developing improvement plans for the Quality System. You'll need to interact with regulatory bodies and ensure that quality operations align with both internal and external standards.

AbbVie requires a Quality Assurance Senior Manager to have at least 8 years of experience in biopharmaceuticals, with a minimum of 4 years in a managerial role. A solid understanding of FDA and GMP regulations is essential. Candidates should hold a bachelor’s degree in a scientific or technical field, with a master’s degree preferred.

At AbbVie, career development is a top priority. As a Quality Assurance Senior Manager, you'll not only manage your team but also be responsible for setting performance expectations, conducting performance reviews, and facilitating the professional growth of your staff to align with their career ambitions and the company’s evolving needs.

The Quality Assurance Senior Manager at AbbVie plays a critical role in ensuring compliance by maintaining a thorough understanding of policies and cGMP regulations. You'll oversee all activities related to drug product manufacturing quality, participate actively during audits, review and approve Quality documents, and provide actionable feedback on deviations and trends.

The Quality Assurance team at AbbVie is structured to promote collaboration across various departments. As the Senior Manager, you'll manage direct reports while working closely with cross-functional teams to address quality concerns and ensure compliance, providing a fantastic front-row seat to impactful decision-making processes throughout the organization.

Absolutely! When discussing your experience with FDA/GMP regulations, highlight specific instances where you've implemented these standards in practices. Describe scenarios where your expertise led to successful audits or improved compliance. Use metrics or examples to illustrate your impact.

In high-pressure environments, it's critical to establish clear priorities and open communication. Discuss your strategies for fostering a supportive team atmosphere, delegating effectively, and ensuring your team remains focused and motivated. Provide an example of a time when your leadership made a difference.

To tackle this question, share a specific example where you identified inefficiencies in a quality process and implemented changes. Discuss the problem, the solution you proposed, and the positive outcomes for the organization. Use quantitative results to underscore your contribution.

Successful audits start with preparation—how you ensure all documentation is in order, engage teams in mock audits, and maintain an open line for feedback is key. Discuss a specific audit experience, what went well, and how your strategies prompted a positive outcome.

Handling non-conformances requires a systematic approach. Explain how you assess the situation, involve your team in root cause analysis, and develop remedial actions. Provide an example of effective problem-solving that led to preventing future occurrences.

Cross-functional collaboration is essential in Quality Assurance. Share examples of successful partnerships with other departments, demonstrating your ability to bridge gaps between teams. Highlight how these collaborations have improved overall product quality and efficiency.

Keeping a team motivated through complexity often comes down to communication and recognition. Discuss your approach to setting clear expectations, regularly checking in on progress, and celebrating milestones or achievements to maintain morale and momentum.

Batch record review is critical in our field. Explain your method for conducting thorough reviews, ensuring compliance with regulations. Illustrate with a specific instance where your diligence caught an issue that could have impacted product quality or compliance.

Continuous improvement is a cornerstone of Quality Assurance. Discuss methodologies you’ve applied, such as Six Sigma or Lean practices, to optimize processes. Provide an example of how these methods led to measurable improvements in quality and efficiency.

Managing performance in Quality Assurance involves setting clear goals, providing consistent feedback, and facilitating growth opportunities. Discuss how you've implemented performance reviews and coaching plans, emphasizing the importance of personal and professional development.