Director Of Quality Assurance

New Opportunity - Director of Quality Assurance NA - CDMO Large Molecule

Irving Knight is pleased to be partnering with a Leading Large Molecule CDMO.

Summary: We are seeking a Director of Quality Assurance to join our team. In this role, you will be responsible for maintaining and ensuring the quality of our large-molecule products. You will oversee all quality assurance activities, including the development and implementation of quality systems, procedures, and policies. Additionally, you will work closely with internal departments and external clients to ensure compliance with regulatory requirements.

Responsibilities:

- Lead the development and implementation of quality systems, procedures, and policies.

- Develop and execute strategies to maintain product quality and compliance with regulatory requirements.

- Oversee the design, implementation, and maintenance of Quality programs.

- Collaborate with stakeholders across the organization to ensure compliance with industry standards.

- Manage and mentor the Quality team.

- Recommend improvements to systems and procedures to enhance product quality and operational efficiency.

- Ensure timely resolution of quality issues, investigate and determine root cause.

Qualifications:

- Bachelor's or Master's degree in Life Sciences or related field.

- Minimum of 10 years of experience in Quality Assurance, with at least 5 years in a leadership role. - Strong understanding of regulatory guidelines and requirements.

- In-depth knowledge of GMP requirements for large molecule manufacturing.

- Ability to lead cross-functional teams and manage multiple projects.

- Excellent communication, leadership, and decision-making skills.

Location - North East, United States (Relocation Package Included)

If this is something that could be interesting to you, please send your Resume to [email protected], and I would be happy to provide some further information.

PLEASE NOTE ONLY INTERESTING CANDIDATES WILL BE CONTACTED