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Quality Manager (Pharmaceutical)

Job Summary:


We are seeking an experienced Quality Manager with a strong background in the pharmaceutical industry to oversee and ensure compliance with quality standards and regulatory requirements. The ideal candidate will be responsible for implementing and maintaining quality assurance processes, managing audits, and driving continuous improvement initiatives.


Responsibilities:
  • Develop, implement, and maintain quality management systems (QMS) in compliance with GMP, FDA, and other regulatory standards.
  • Oversee quality control processes and ensure adherence to SOPs, regulatory requirements, and company policies.
  • Manage internal and external audits, ensuring proper documentation and corrective actions.
  • Lead quality risk management efforts and implement necessary improvements.
  • Coordinate with cross-functional teams to ensure product quality and compliance.
  • Train and mentor staff on quality procedures and regulatory expectations.
  • Investigate and resolve quality-related issues, implementing corrective and preventive actions (CAPA).
  • Maintain documentation for regulatory inspections and ensure readiness for compliance audits.
  • Collaborate with suppliers and vendors to ensure quality standards are met.
  • Monitor and report on key quality performance metrics, driving continuous improvement initiatives.


$80,000 - $105,000 a year
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Average salary estimate

$92500 / YEARLY (est.)
min
max
$80000K
$105000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Quality Manager (Pharmaceutical), Latitude Inc

Are you ready to take the reins as a Quality Manager at an exciting pharmaceutical company in beautiful Orlando, FL? We’re on the lookout for an experienced Quality Manager who is not just passionate about compliance, but also driven by the pursuit of continuous improvement in our quality assurance processes. In this role, you will develop, implement, and maintain quality management systems that align with Good Manufacturing Practices (GMP) and FDA regulations. Your expertise will ensure we stay aligned with the highest quality standards. You’ll oversee quality control processes, manage both internal and external audits, and work closely with cross-functional teams to ensure that our products are not just good, but exceptional. Training and mentoring our staff on quality procedures will be a key part of your role, as will investigating quality-related issues, with the responsibility to implement effective corrective and preventive actions. This is an opportunity to make a real impact, reporting on key quality performance metrics that drive our continuous improvement initiatives. With a salary range of $80,000 to $105,000 a year, joining us as the Quality Manager means you’ll be at the forefront of delivering unparalleled quality in a dynamic environment. Are you ready to elevate your career with us?

Frequently Asked Questions (FAQs) for Quality Manager (Pharmaceutical) Role at Latitude Inc
What are the key responsibilities of a Quality Manager at our pharmaceutical company?

As a Quality Manager at our pharmaceutical company, your main responsibilities will include developing and maintaining quality management systems compliant with GMP and FDA regulations, overseeing quality control processes, managing audits, implementing CAPA, and collaborating with cross-functional teams to ensure product quality.

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What qualifications are required for the Quality Manager position?

The Quality Manager position requires a strong background in the pharmaceutical industry, extensive knowledge of regulatory standards such as GMP and FDA, as well as experience with quality assurance processes. A degree in a related field and relevant certifications will be highly regarded.

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How does the Quality Manager contribute to product quality and compliance?

The Quality Manager plays a critical role in product quality and compliance through the development and oversight of quality assurance and control processes, training staff, resolving quality-related issues, and ensuring strict adherence to regulatory standards.

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What kind of training will the Quality Manager provide to staff?

As a Quality Manager, you will provide training on quality procedures and regulatory expectations, ensuring that all team members are well-versed in compliance requirements and internal SOPs to maintain high-quality standards in our processes.

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How does the Quality Manager handle audits and inspections?

The Quality Manager will be responsible for managing both internal and external audits, ensuring proper documentation is maintained, corrective actions are implemented, and the company is always prepared for regulatory inspections.

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Common Interview Questions for Quality Manager (Pharmaceutical)
What quality management systems are you familiar with?

In your response, highlight specific quality management systems you have worked with, emphasizing your experience with GMP and FDA compliance, and how you have successfully implemented or maintained these systems.

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Can you describe your experience with CAPA processes?

Share examples of how you have identified quality issues, implemented corrective actions, and followed through to ensure those actions effectively resolved the problems, showcasing your analytical and problem-solving skills.

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How do you ensure compliance with regulatory standards?

Discuss your approach to staying up-to-date with regulatory changes, conducting regular training sessions for staff, and your methods for maintaining meticulous documentation to ensure compliance at every level.

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Describe a time when you successfully led a quality improvement initiative.

Provide a specific example that outlines the initiative, your strategic approach, the results you achieved, and how you involved various teams to enhance product quality.

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What steps do you take when preparing for an audit?

Explain your thorough preparation process, including how you ensure that all documentation is in order, staff is trained and informed, and any previous audit findings have been addressed.

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How do you handle conflicts within a quality team?

Share strategies for fostering collaboration and communication, addressing conflicts directly while focusing on finding a solution that aligns with quality objectives and company values.

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What metrics do you use to monitor quality performance?

Mention key performance indicators (KPIs) you have tracked, including defect rates, compliance scores, and the effectiveness of quality initiatives, and how you report these metrics to senior management.

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How do you train and mentor staff on quality assurance practices?

Illustrate your training techniques, whether it involves hands-on workshops, structured training sessions, or continual performance feedback, to engage and educate team members on quality assurance requirements.

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What is your experience with risk management in quality processes?

Discuss your approach to identifying, assessing, and mitigating risks in quality, providing examples demonstrating your proactive measures to avoid potential quality issues.

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Why do you want to work as a Quality Manager in our pharmaceutical company?

Express your enthusiasm for the position by aligning your values with the company's mission, emphasizing your passion for quality in pharmaceuticals and the impact it has on patient safety and product integrity.

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Take Risks
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Pet Friendly
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Latitude is a Human Resource Consulting Firm headquartered in Hanover, MD with branch offices in Hunt Valley, MD and Winter Park, FL. Latitude provides consulting services to a wide range of industries in both the Private and Public Sectors. We ar...

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DATE POSTED
March 12, 2025

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