QA Supervisor, Change Control
Competitive compensation package and growth opportunities
Working with industry leaders and partnering with top competitors
About Our Client
Leading global bio-pharmaceutical company based in New Jersey focused on CAR-T cell therapy. Part of a global strategic collaboration working with industry experts and top competitors to advance their practice.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Lead efforts to establish and streamline the site change control process.
- Act as the change control champion by owning the change control process from initiation through completion.
- Schedule and manage the site change control review board meetings.
- Manage change control metrics reporting.
- Review and approve change controls, SOPs, and other documentation.
- Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
- Detailed knowledge of Quality and Compliance standards.
The Successful Applicant
- Minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
- Minimum of 6 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 2 years of experience with quality support in clinical manufacture is preferred. A minimum of 1 year of leadership experience is also required.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
- 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.
What's on Offer
Competitive salary and growth opportunities, alongside working with industry leaders.