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Senior Manager Quality Engineering (JP7980)

Thousand Oaks, Ca · Biotech/Pharmaceutical
Job Title:  Senior Manager Quality Engineering (JP7980)
Location: Thousand Oaks, CA (Onsite pending lifting of COVID restrictions next year).
Employment Type:  Contract
Business Unit: Final Product Technologies Quality
Duration: 1+ years (with likely extensions)
Posting Date: 12/3/20
3 Key Consulting is hiring a Senior Manager Quality Engineering for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
  • Accountable to provide Quality oversight of Final Product Technologies (FP) method stewardship, modeling, and material characterization.
  • Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to FP Core Technologies and/or to sites.
  • Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance, and time to market.
  • Ensures alignment strategies for methods transfer across multiple sites.
  • Works with External Supply Quality and/or other quality counterparts to ensure there is a robust plan in place when receiving methods from a CMO or supplier.
  • Provides Quality oversight to final product core technologies activities and deliverables.
  • Quality approval of protocols and technical reports for method development.
Why is the Position Open?
Additional workload on the team.
Top Must-Have Skill Sets:
  • Hard skills (5+ years of experience).
  • Validation Qualifications experience.
  • Combination process / Medical Devices experience.
  • GMP experience (quality management systems, manufacturing).
  • Audits / Inspections experience.
  • Leadership skills.
Basic Qualifications:
Masters/Bachelors Degree in Science or Business.
Employee Value Proposition:
Working at a great biotech/pharma company, working with a dynamic team on challenging concepts, growing your skill set in the role.
Red Flags:
  • Transparency.
  • Not able to work in a fast-paced environment.
  • No time management experience.
  • Lack of independence.
Interview process:
Video Skype Panel Interview.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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