Job Title: Director of Quality Assurance
Location: New Jersey
Position Overview:
We are seeking a highly experienced and motivated Director of Quality Assurance to lead a QA team in New Jersey. The ideal candidate will have a strong background in aseptic manufacturing and a proven track record in quality assurance within a CDMO environment. This role will be responsible for overseeing quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.
Key Responsibilities:
- Develop and implement the quality assurance strategy for aseptic manufacturing operations, ensuring alignment with company goals and regulatory requirements.
- Oversee the quality assurance team, providing leadership, guidance, and support to ensure effective quality oversight throughout the manufacturing process.
- Establish and maintain robust quality management systems (QMS) to ensure compliance with FDA, EMA, and other relevant regulatory agencies.
- Lead investigations and root cause analysis for quality events, deviations, and non-conformances, implementing corrective and preventive actions (CAPA) as needed.
- Collaborate with cross-functional teams, including manufacturing, engineering, and regulatory affairs, to ensure quality is integrated into all aspects of the manufacturing process.
- Conduct regular audits and inspections of manufacturing processes, facilities, and systems to ensure compliance with internal standards and external regulations.
- Stay abreast of industry trends, regulatory changes, and best practices in aseptic manufacturing and quality assurance.
- Manage a team with 10 direct reports.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance within a pharmaceutical or biotechnology environment, with at least 5 years in a leadership role.
- Extensive knowledge of aseptic manufacturing processes, quality systems, and regulatory requirements.
- Strong analytical skills and experience in quality investigations and root cause analysis.
- Proven ability to lead and develop high-performing teams, fostering a culture of quality and continuous improvement.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with various stakeholders.
