BioPharma Quality Compliance Manager - Oregon Freeze Dry

BioPharma Quality Compliance Manager

Who?

Does BioPharma Quality Compliance Manager sound like your next job title?

This exciting opportunity is offered by Oregon Freeze Dry. We are a World Class, purpose-driven technology solutions company with nearly six decades of freeze-drying expertise.  We find inspiration in our ability to create solutions, through the science and craft of lyophilization, that improve the lives of individuals and communities around the globe. Our driven and passionate team needs to expand, as we continue to experience sustainable growth across multiple markets. 

What?

The BioPharma Quality Manager oversees the quality assurance and quality control processes within the Life Sciences Division of Oregon Freeze Dry. This role involves ensuring compliance with regulatory requirements; developing, managing, and enhancing quality systems to meet current business needs as well as enhancing the quality system to support upcoming business needs; and managing the BioPharma quality team.

This position will also develop partnerships with key enterprise business partners, stakeholders and customers to advance solutions and enable transparency, escalation, and resolution of quality and compliance matters; fostering openness and collaboration to achieve goals within the appropriate risk mitigating environment.

Main aspects of the role include:

1. Develop, plans, implements and ensures an effective Quality Program
2. Ensure compliance with regulatory requirements and industry expectations for all aspects of BioPharma activities, including: Quality, Production, Facilities/Equipment, Laboratory, Materials, Packaging and Product Development
3. Reviews/approves all protocols for facility, equipment, process, material testing and analytical method development.
4. Oversees the development and execution of quality control tests and inspections
5. Audits manufacturing practices and processes for compliance to all customer and regulatory requirements.
6. Works alongside OFD Safety Officer and Bio Safety Officer to ensure employee, environment and products are not impacted by hazardous materials and/or processes for commercial, development and clinical activities and measures.
7. Leads Complaint Reviews/Responses in a timely manner, including corrective/preventive action(s) where appropriate.
8. Oversees investigation, disposition and communication of rejected material(s)/component(s)

You!

The ideal candidate will have a Bachelor of Science degree in Microbiology, Chemistry, Biochemistry and/or related fields with 5 years experience in the pharmaceutical industry specifically in regards to quality regulatory, with at least 2 years in a leadership role. This candidate should have knowledge of pharma industry regulations, standards (i.e. 9001, 13485, 21CFR 210, 820) and quality management systems, including previous commercial application, and industry best practices.

The individual should have the ability to apply understanding of statistical analysis methods and applications in process optimization and development, including previous experience applying these concepts to quality programs. In addition, strong computer skills, experience working on cross-functional teams, and effective communication skills are desired.

Curious? Apply with your resume at Careers | Oregon Freeze Dry (ofd.com) or you can find more information about our company on our website.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…