What are the responsibilities and job description for the Quality Assurance Associate position at Barrington James?
The Associate Director of Quality Affairs will play a pivotal role in ensuring that our small molecule pharmaceutical products meet the highest quality standards. This position will oversee the quality management system, ensure compliance with regulatory requirements, and lead quality assurance and control activities. The ideal candidate will have a deep understanding of GMP regulations, experience in quality oversight, and a proven track record of successfully navigating quality challenges in the pharmaceutical industry.
Key Responsibilities:
- Quality Management System (QMS): Oversee and maintain the QMS to ensure it meets regulatory standards and supports business objectives.
- Regulatory Compliance: Ensure all products comply with FDA, EMA, and other relevant regulatory bodies' requirements. Stay updated on changing regulations and ensure the company’s practices are aligned.
- Audits and Inspections: Lead internal and external audits, manage responses to findings, and ensure timely and effective corrective and preventive actions (CAPA).
- Documentation: Oversee the creation, review, and approval of quality-related documents, including SOPs, batch records, validation protocols, and product specifications.
- Product Quality: Ensure product quality throughout the development, manufacturing, and distribution processes. Collaborate with cross-functional teams to address quality issues.
- Leadership and Development: Manage and mentor a team of quality professionals, fostering a culture of continuous improvement and regulatory excellence.
- Risk Management: Identify and assess quality risks, implement mitigation strategies, and manage deviations and non-conformances.
- Supplier Quality Management: Oversee the qualification and monitoring of suppliers, ensuring that raw materials, components, and services meet quality standards.
- Continuous Improvement: Drive initiatives to enhance quality processes and systems, ensuring best practices are adopted and maintained across the organization.
Qualifications:
- Education: Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or a related field. An advanced degree (MS, PhD) or relevant certification (e.g., ASQ, CQA) is preferred.
- Experience: Minimum of 1-3 years of experience in pharmaceutical quality assurance/quality control. Experience in small molecule pharmaceuticals is highly desirable.
- Regulatory Knowledge: In-depth knowledge of cGMP, ICH guidelines, FDA, EMA, and other global regulatory requirements.
- Skills: Strong leadership, project management, and problem-solving skills. Excellent communication skills, both written and verbal.
- Software Proficiency: Familiarity with electronic QMS, LIMS, and other quality-related software systems.
- Personal Attributes: Detail-oriented, strategic thinker with the ability to work in a fast-paced, dynamic environment.
Please note that we can’t provide H1B sponsorship for this role
