Quality Site Head – Internal Manufacturing Jobs

Must have excellent organizational, management, and people development skills.

Develops and manages budget, organizational structure and business requirements to accommodate business needs and assure meeting JSC metrics.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

The incumbent must have 9 years QA/QC experience in the pharmaceutical industry.

Strong knowledge in regulatory compliance, Quality Systems, pharmaceutical industry, pharmaceutical methods and procedures

Must use interpersonal and teamwork skills to build interdependent partnerships.

Knowledge and experience in the implementation and maintenance of a Quality Management System.

Thorough understanding of the elements of the Quality Management Systems and ISO 9001 requirements and tools.

Project Management skills and ability to perform multiple tasks simultaneously.

Expected to perform management tasks of organizing, motivating, communicating and measuring department personnel activity.

Defines, enhances and improves Plant Quality Management System.

Performs situation task force management.

Ability to maintain professional competence, knowledge, and skills necessary for fulfilling assigned responsibilities satisfactorily.

Deliver training and coaching on quality-related matters to production associates and management.

Report project progress using the A3 project management process/format.

Extensive experience in Manufacturing Quality Engineering.

Strong computer skills, including Word, Excel, and PowerPoint.

Excellent written and verbal communication skills with a collaborative mindset.

BS in Construction Management or Engineering or equivalent work experience.

Experience in personnel management, and staffing and scheduling.

Experience in contractor, consultant and vendor management.

Provide training of personnel to ensure awareness of quality procedures and specific responsibilities in the QA/QC process.

7+ years’ experience in quality control & quality assurance (QA/QC) programs for data centers or mission critical construction projects.

Experience with Design-Build and Design-Bid-Build construction programs.

Develop clear accountabilities and handoffs between the process development, MS&T and technical operations organizations.

BS in a scientific or related field with 10+ years progressive leadership experience in a biotechnology or pharmaceutical company

CDMO industry experience would be highly desirable.

Experience with global supply chains for biologics and/or advanced therapies

Deliver strategic leadership and vision to ensure successful scale up of client-specific manufacturing programs.

Promote scientific rigor and ensure industry-leading manufacturing operations.

Certifications in quality management (e.g., Six Sigma, Lean) are highly desirable.

Establish and maintain a robust quality management system, including documentation control, change control, and deviation management.

Strong knowledge of regulatory requirements, such as FDA regulations, GMP guidelines, and ICH guidelines.

Proven track record of implementing and managing a quality management system in accordance with industry standards.

Collaborate with cross-functional teams to ensure quality requirements are met throughout the product lifecycle, from development to manufacturing and distribution.

Minimum of 10 years of progressive experience in quality assurance and quality control in the biotech or pharmaceutical industry.

Responsible for end-to-end Quality within the site, including FUSE qualification/validation, materials management, batch record reviews, change control, and deviations

Collaborate with internal partners to enable compliant and successful manufacturing (e.g. technology transfers, validation, testing, and lifecycle management)

Direct experience hosting Health Authority inspections

Prior experience in the manufacture of cell and gene therapy products

Provide strategic direction and operational leadership for the site Quality function at CRISPR’s internal manufacturing facility

Chair the site Quality Review Board and establish quality metrics to demonstrate adherence to GMP regulations and CRISPR procedures