Title: Director of Quality Control
Summary: A leading CDMO is currently seeking a strong and motivated individual to help oversee operations at their site. At this rapidly growing organization, located in Iowa, you would be responsible for managing and directing the Quality Control laboratories, leading the Process Support, Raw Materials, Quality Control, and Stability operations located at their site. You will get the opportunity to certify that all operations are in compliance with various regulations, and that systems and resources are running smoothly to ensure that client, customer, and project needs are met in a timely manner. Are you ready for the next step in your quality career? Please reach out to learn more.
The Director of Quality Control will be responsible for:
- Directing the implantation and execution of controls data integrity, documentation, sample management, reagent and reference standard management, and instrument and equipment management controls
- Developing and maintaining a term of analysts and personnel to maintain high levels of compliance and inspection readiness
- Reviewing and approving instrument and method qualification/validation and transfer protocols and reports
- Managing, with stakeholders, any QC activities that affect production and validation activities
- Managing the Deviation program process within the laboratories
The Director of Quality Control should have the following qualifications:
- Bachelor's degree in Science with a major in Life Sciences, Biochemistry, Chemistry, or Pharmacology with at least 15 years of experience in GMP positions OR Master's degree with 12 years of experience OR Ph.D degree with 10 years of experience
- Minimum 7 years' experience in a Supervisory role in either Quality Assurance or Quality Control
- In depth knowledge of GMP Regulations and guidance of US-FDA, EU in particular data integrity and various compendia
- Ability to serve as subject matter expert with clients and regulatory bodies for quality issues/investigations
- Relocation package
- Above average benefits
Don't hesitate, apply today! You can also contact Lenin at 312-854-0557 with any questions or to learn more.