What are the responsibilities and job description for the Pharmaceutical Quality Assurance Manager position at SynergenX?
Job Description
Job Description
TomorrowMed Pharma is a pioneering 503B manufacturing facility poised to revolutionize the pharmaceutical compounding industry. Situated in the heart of Research Triangle Park in Raleigh, NC, this brand-new cutting-edge cGMP facility adheres to strict regulatory standards set by the FDA to ensure the safety, efficacy, and quality of all our products. At TomorrowMed Pharma, we are committed to setting new standards in quality, innovation, and patient-centric care.
Driven by a passion for healthcare and a commitment to continuous improvement, we are constantly exploring new opportunities for growth and innovation in the compounding industry. With a collaborative and supportive work environment, we empower our employees to thrive and make meaningful contributions to our mission of enhancing patient care through customized medication solutions.
Join us in our pursuit of excellence and become a valued member of our team as we continue to lead the way in 503B pharmaceutical manufacturing.
The Quality Assurance Manager will oversee and manage all quality assurance activities for TomorrowMed Pharma. This individual will be responsible for ensuring compliance with FDA regulations, cGMP (current Good Manufacturing Practices), and internal policies and procedures. The Quality Assurance Manager will play a critical role in maintaining the highest standards of product quality and safety while fostering a culture of continuous improvement.
Regulatory Compliance :
- Ensure the facility's compliance with FDA regulations, including 21 CFR Part 210, 211, and 503B.
- Develop, implement, and monitor quality systems and procedures to comply with cGMP requirements.
- Prepare for and manage FDA inspections, including responding to Form 483 observations and Warning Letters.
- Maintain up-to-date knowledge of regulatory changes and ensure that the facility remains compliant.
- Develop and maintain relationships with regulatory bodies and agencies to ensure compliance with regulations.
Quality Systems Management :
Product Release :
Team Leadership :
Continuous Improvement :
Qualifications / Requirements :
Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) required.
Advanced degree (e.g., MS, PhD) or relevant certifications (e.g., ASQ Certified Quality Auditor, Six Sigma) preferred.
Minimum of 7-10 years of experience in Quality Assurance within the pharmaceutical or biotechnology manufacturing industry, with at least 3-5 years in a management role.
In-depth knowledge of FDA regulations, cGMP, and 503B outsourcing requirements.
Experience with quality systems, regulatory inspections, and product release in a highly regulated environment.
Experience with parenteral, formulation, Validation of equipment and processes, aseptic processing, Vial and injectable filling, Auditing (both internal and external), Environmental Monitoring, Running an overall Quality Management System including developing and maintaining the system, Supplier management, Batch record review and release.
Location :
Facility Located in Raleigh, NC 27560 in the heart of Research Triangle Park
Comprehensive benefit package is included!
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