- Join an expanding CDMO supporting Phase I, II, & III clinical studies
- Become the QA Head of a highly dynamic team.
About Our Client
Company is a Contract Research Manufacturing Organization (CDMO) offering a full range of pharmaceutical product development services from pre-formulation, through aseptic manufacturing and stability, supporting Phase I, II, & III clinical studies.
- Directs the development and implementation of Quality Management System goals.
- Over see Quality Management System essentials.
- Timely review and approval of batch records, quality agreements, vendor qualification documents and analytical/microbiology records.
- Approve investigations, risk assessments, deviations, CAPA, change records, etc. and recommend corrective actions/CAPAs related to cGMP and QMS issues
- Proactively identify compliance issues/risks, within the organization
- Contribute effectively to the accomplishment of team or work unit goals, objectives and activities.
- Building the QA team to support the company's growth
- Manage all customer, supplier or regulatory audits.
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.
The Successful Applicant
- Bachelor's degree in Chemistry or related field preferable.
- Minumum of 10 years in QA Management, in FDA regulated, clinical trials, pharma manufacturing and lboratory envirnoment.
- Expert knowledge of GMP and FDA regulatory requirements.
What's on Offer
- Competitive compensation package and benefits.
- Opportunity to lead a highliy motivated QA team.