Skip to main content

This job has expired

You will need to login before you can apply for a job.

Senior Manager, QA Operations

Employer
Just - Evotec Biologics
Location
Seattle, WA
Start date
Apr 1, 2023

View more

Discipline
Manufacturing & Production, Operations, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioForest

Senior Manager, Quality Assurance Operations | Just. – Seattle, WA |

Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant experience in leading all Quality Assurance and batch disposition activities related to the manufacturing of biological products. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.

Responsibilities:

  • Lead and mentor 3 direct reports in execution of quality operations responsibilities
  • Lead and direct all aspects of the Quality Assurance function to assure compliance with quality and industry regulatory requirements
  • Support QA review and approval of Master Batch Records, Executed Batch Records, Product Specifications and Quality Control Analytical data.
  • Direct and manage the QA assessment and review of investigations and approval of NC/CAPA/Change control documentation.
  • Oversee product shipments for cell banks, drug substance, and placebo
  • Manage the QA communication and lot disposition process with CDMO client base
  • Support internal and client audits of the quality management systems
  • Implement process performance and product quality monitoring programs
  • Continue to build and enhance various Quality Assurance programs by guiding individuals through the maturation process.
  • Alert senior management of significant quality, compliance, supply, and safety risks

Educational Requirements:

  • Bachelors degree in biological or engineering science with 8+ years relevant experience

Preferred Qualifications:

  • Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company
  • Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making
  • Expertise in tools, concepts, and methodologies of QA
  • Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
  • Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams

The base pay range for this position at commencement of employment is expected to be $140,000 to $170.000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert