Associate Director Quality Assurance
1 week ago
Job Title: Senior Quality Manager / Associate Director
Industry: Generics Pharmaceutical Manufacturing
About the Company:
Arevna is partnering with a fast-growing biopharmaceutical company based in Texas. This innovative organization is expanding its operations and is seeking a dynamic Senior Quality Manager/Associate Director to lead key quality initiatives and ensure compliance in a regulated generics manufacturing environment.
Key Requirement:
Candidates must have hands-on experience in generics development and a strong understanding of Chemistry, Manufacturing, and Controls (CMC).
Role Overview:
In this critical role, you will manage the quality assurance systems and processes, ensuring compliance with FDA regulations and GMP standards. You will play a significant role in the preparation and management of ANDA submissions and provide strategic guidance on quality issues.
Key Responsibilities:
- Develop, implement, and maintain quality systems, including CAPA, change control, deviation management, and audit programs.
- Lead or support the preparation of ANDA filings, ensuring compliance with CMC requirements.
- Collaborate with regulatory, manufacturing, and R&D teams to address quality-related aspects of generics development.
- Support internal and external audits, ensuring readiness for FDA and other regulatory inspections.
- Oversee supplier and vendor qualification processes to ensure compliance with quality standards.
- Conduct risk assessments and contribute to continuous improvement initiatives in quality systems.
- Train and mentor team members on quality practices and regulatory compliance.
Qualifications:
- Bachelor’s degree in a scientific or technical discipline; advanced degree preferred.
- 5+ years of quality assurance experience in a regulated pharmaceutical environment, with a focus on generics manufacturing.
- Strong knowledge of FDA regulations, GMP standards, and CMC processes.
- Proven experience supporting ANDA submissions.
- Excellent problem-solving skills, with a demonstrated ability to lead root cause analysis and implement effective CAPAs.
- Strong interpersonal and communication skills with the ability to work collaboratively across teams.
Compensation:
Competitive salary package, with opportunities for professional growth and development.
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