Senior Manager Quality Engineering (JP7980)
Thousand Oaks, CA (Onsite pending lifting of COVID restrictions next year).
Final Product Technologies Quality
1+ years (with likely extensions)
3 Key Consulting is hiring a Senior Manager Quality Engineering
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Why is the Position Open?
- 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.
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.
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.
- Not able to work in a fast-paced environment.
- No time management experience.
- Lack of independence.
Video Skype Panel Interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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.