- Lead and manage the Quality Organization effectively.
- Establish and uphold the quality system to meet regulatory and cGMP standards.
- Develop and execute the Quality strategy for project developments.
- Promote Quality advocacy and Best Practices adoption.
- Ensure teams follow Quality Strategy principles, guidelines, and best practices.
- Motivate teams, identify talent, and foster continuous improvement.
- Analyze, define, and lead process enhancements.
- Cultivate a culture of ongoing improvement.
- Ensure staff receives adequate training and meets compliance requirements.
- Lead vendor audits and FDA inspections.
- Perform any other duties as directed by management.
- Bachelor's degree in a scientific field with at least 5 years of quality management experience OR
- Master's degree in a scientific field with a minimum of 3 years of quality management experience
- Essential experience in Pharmaceutical Manufacturing.
- Prior experience in an FDA-regulated environment.
- Knowledge of CFR & ICH Regulatory Guidelines.
- Familiarity with cGMP processes.
- Required skills in Word, Excel, and PowerPoint.
- Demonstrates exceptional cGMP documentation abilities.
- Strong organizational and multitasking skills in a fast-paced setting.
- Trustworthy with a commitment to confidentiality.
- Proficient in problem analysis, solving, and resolution.
- Excellent verbal and written communication.
- Outstanding interpersonal skills.
- Highly self-motivated with keen attention to detail.
- Maintains a positive attitude and promotes teamwork.
- Fluency in English (speaking, reading, and writing).
- Highly organized with exceptional attention to detail.
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Quality Assurance Manager - Fairfield, United States - Garonit Pharmaceutical
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Description
Summary:
This position will mainly focus on Pharmaceutical Manufacturing, which requires a background in this specific field. The ideal candidate will be responsible for managing the establishment, development, and maintenance of Quality Systems, policies, procedures, and controls, ensuring that the performance and quality of cGMP documentation and records adhere to set standards. The QA Manager's primary focus will be to promote a culture of quality responsibility throughout the organization, ensuring a high level of GxP Compliance. Additionally, the role will oversee the alignment of all Quality processes with business needs and Health authority expectations, striving for a collaborative Quality organization that meets both internal and external customer satisfaction. The ultimate objective is to enhance business effectiveness by coaching, supporting, and implementing quality management systems and tools while fostering a quality mindset.
Working Hours:
Standard Hours: 8:30 AM - 5:00 PM, Monday to Friday
Occasionally, extended hours and weekend work may be necessary to support business requirements.
Key Responsibilities:
Qualifications:
Computer Proficiency:
Additional Requirements:
