Pharmaceutical Quality Assurance Manager

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 :

• Oversee the development, implementation, and maintenance of the Quality Management System (QMS).
• Lead investigations into product quality issues, deviations, CAPAs (Corrective and Preventive Actions), and customer complaints.
• Conduct regular audits and inspections to ensure compliance with quality standards and identify areas for improvement.
• Manage the document control system, including the review and approval of SOPs, batch records, and validation protocols.

Product Release :

• Supervise the batch release process, ensuring that all products meet quality specifications before distribution.
• Review and approve batch records, certificates of analysis, and other documentation required for product release.
• Ensure that all testing, including in-process, release, and stability testing, is performed in compliance with established standards.

Team Leadership :

• Lead, mentor, and develop the Quality Assurance team, providing guidance on quality principles and practices and monitoring performance.
• Lead and assist with hiring and interviewing of new Quality Assurance employees.
• Provide coaching and counseling to Quality Assurance personnel.
• Foster a culture of quality and continuous improvement throughout the organization.
• Develop training programs and ensure that all staff members are adequately trained in quality and regulatory requirements.

Continuous Improvement :

• Identify areas for process improvements and lead initiatives to enhance product quality, efficiency, and compliance.
• Collaborate with cross-functional teams, including Production, R&D, and Supply Chain, to drive quality improvements and operational excellence.
• Implement risk management strategies to proactively identify and mitigate potential quality issues.
• Lead and facilitate internal and external quality audits.

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 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.

Location :

Facility Located in Raleigh, NC 27560 in the heart of Research Triangle Park

Comprehensive benefit package is included!

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