BioPharma Quality Compliance Manager

2 days ago


Albany, Oregon, United States Oregon Freeze Dry Full time
Job Title: BioPharma Quality Compliance Manager

At Oregon Freeze Dry, we are seeking a highly skilled BioPharma Quality Compliance Manager to join our Life Sciences Division. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and developing effective quality systems to meet current business needs.

Main Responsibilities:

  • Develop and implement quality programs to ensure compliance with regulatory requirements and industry expectations.
  • Review and approve protocols for facility, equipment, process, material testing, and analytical method development.
  • Oversee the development and execution of quality control tests and inspections.
  • Audit manufacturing practices and processes for compliance to customer and regulatory requirements.
  • Work with the Safety Officer and Bio Safety Officer to ensure employee, environment, and product safety.
  • Lead complaint reviews and responses, including corrective/preventive actions.
  • Oversee investigation, disposition, and communication of rejected materials/components.

Requirements:

  • Bachelor of Science degree in Microbiology, Chemistry, Biochemistry, or related field.
  • 5 years of experience in the pharmaceutical industry, specifically in quality regulatory, with at least 2 years in a leadership role.
  • Knowledge of pharma industry regulations, standards, and quality management systems.
  • Ability to apply statistical analysis methods and applications in process optimization and development.
  • Strong computer skills, experience working on cross-functional teams, and effective communication skills.

About 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 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.

Equal Opportunity Employer:

Oregon Freeze Dry wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination. We are an Affirmative Action/Equal Opportunity Employer and a drug-free workplace.



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