Department: Azzur Cleanrooms-On-Demand-Services LLC
Job Description
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.
- A primary point of contact and decision maker for quality activities and quality deviating events related to facilities, utilities, systems, equipment, supplier qualification, and client operations at the Azzur facilities.
- Quality contact and decision maker for review/approval of all Azzur documents, including but not limited to Policies, SOPs, protocols, reports etc.
- Responsible for ensuring Azzur’s quality of service delivery is met for all clients per internal procedures and client quality agreements/scopes of work.
- Identify, implement, and manage quality improvement and operational excellence projects to support site efficiency.
- Ensures overall compliance with Azzur Group Policies and Procedures at
Azzur facilities. - Coaching, developing, and motivating direct report/s to maximize performance & potential.
Requirements:
- 7-10 years of experience in Quality assurance or Quality control in Biopharma/medical device industries.
- Bachelor's degree in Science or other related fields or equivalent experience.
- Previous managerial or supervisory experience.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Implementing and identifying quality improvement opportunities and operational excellence
projects such as 5S, Kanban, process mapping, risk assessments, and kaizen.
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Diversity and inclusion initiatives
- Employees Recognition Program
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 adequately 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.
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