The quality manager's primary responsibility is to manage local COD Quality policies, procedures, and processes in compliance with cGMP standards and Azzur business processes.
- Manage the activities of the Quality System to ensure compliance with global and local COD quality requirements.
- Manage the Document Control function locally, including the initiation, control, maintenance, and review of all COD-Waltham documents.
- Manage Non-conformance Reporting and Corrective Action Preventive Action functions locally.
- Conduct or assist in internal and external audits related to COD service delivery.
- Manage site staffing, development, and performance management of all qualified personnel.
- Assist in the development of site quality metrics. Maintain and manage quality metrics locally for management reviews and continuous improvement initiatives.
- Oversee the Quality Function of material release assure cGMP compliance.
- Assist in Client Technical Transfer to ensure all aspects of the quality agreement are met.
- Assist as needed with quality functions such as supplier management/audits, on-site/remote client audit support, audit responses, Quality Agreements, COD Quality Management Reviews, and continuous improvement activities related to the Waltham site.
- A minimum of 5-7 years of experience in the biopharma industry increases responsibility within Quality Management functions.
- Previous managerial or supervisory experience.
- Experience with FDA and other similar regulations related to cGMP manufacturing and quality management.
- Experience with quality management systems related to cGMP activities in the biopharma industry.
- Experience with electronic documentation/quality management systems in a regulated environment.
- CQA/CQE or similar quality certification.
- Experience performing supplier/vendor audits.
- Experience with cell and gene therapy-related equipment and processes.
- Experience in early phase manufacturing guidances (PDA TR 56)
- Experience in managing Environmental Monitoring programs
- Experience implementing and managing Raw Material programs
- Experience implementing and maintaining Operational Excellence programs
- Microsoft Office
- Microsoft Visio
- eQMS, eLMS, eDMS
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:
- Put Others First,
- Have the Courage to Take Action,
- Take Personal Responsibility, and
- Have Fun!
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.