Role Overview
The Associate Manager/Manager, Quality Control is an exempt level position with responsibilities for managing the operation and worklflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.
Major Responsibilities:
Ensuring adequate training (skills-based, cGMP and safety) of associates within the department.
Raw material, in-process, environmental/utility, product release, and stability testing.
Investigation of laboratory non-conformances (events, deviations, and invalid assays).
Maintenance, calibration and qualification of laboratory instruments and equipment.
Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing.
Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.
Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on the-job training requirements.
Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision.
Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Other duties will be assigned, as necessary
Profile
Education:
A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
Experience:
A minimum of 8 to 10 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 1 to 4 years of leadership experience is also required.
Capabilities, Knowledge, and skills:
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Strong interpersonal and written/oral communication skills.
Proven people management and leadership experience is required.
Experience working with quality systems is required.
Extensive knowledge of chemical, biochemical and microbiological concepts is required.
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
Proficient in applying process excellence tools and methodologies.
The candidate must be highly organized and capable of working in a team environment with a positive attitude.
Good written and verbal communication skills are required.
Ability to summarize and present results, and experience with team-based collaborations is a requirement.
Experience developing and setting long-term objectives.
Ability to identify/remediate gaps in processes or systems
Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
This position may require up to 10% domestic or international travel as business demands
Language(s): Dutch