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 initiating, controlling, maintaining, and reviewing all COD-NC 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 to 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 Quality Management functions.
- Bachelors degree in Science or other related fields or equivalent experience.
- 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.
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 CODAs you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on DemandTM is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on DemandTM mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing phase-appropriate GMP for industry leaders.
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 we operate.