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Quality Assurance Manager, Biopharma – Remote (JP10218)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Quality Assurance Manager, Biopharma – Remote (JP10218)
Location: Thousand Oaks, CA. (Remote - EST & PST flexibility preferred)
Employment Type:  Contract
Business Unit: 
Corporate Quality Assurance
Duration: 8 months with likely extensions
Posting Date:  5/16/2022

3 Key Consulting is hiring a Quality Assurance Manager for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Remote position; EST and PST hours preferred. In support of client’s Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility



FUNCTIONS:
  • Responsible for hiring, training, supervising and performance management of staff.
  • May perform or oversee the following functions:
    • Review and approve product MPs
    • Approve process validation protocols and reports for Mfg. processes.
    • Approve Environmental Characterization reports
    • Approve planned incidents
    • Represent QA on NPI team
    • Lead investigations
    • Lead plant audits, participate in site audits
    • Approve change-over completion
    • May perform work of QA Specialist

EDUCATION/LICENSES
Doctorate degree or Master’s degree and 3 years of directly related experience or
Bachelor’s degree and 5 years of directly related experience.
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.


COMPETENCIES/SKILLS
  • Project management skills
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Collaborate and communicate with higher level outside resources.
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
  • Strong communication (both written and oral), facilitation, and presentation skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • Ability to lead and influence staff outside own organization.
  • Ability to motivate staff and manage and distribute work loads.
  • Able to manage performance issues and conflict
  • Ability to provide direction and establish goals for individual staff members and work group.
  • Ability to evaluate documentation/ operations according to company and regulatory guidelines
  • Ability to interact with regulatory agencies
  • Demonstrate the company Values/Leadership Practices
     
Preferred Qualification
Available to work in 2nd shift and non-standard shift.?



Why is the Position Open?
Staff Augmentation

Top Must-Have Skill Sets:
  • Computerized System Periodic Review
  • Validation experience
  • Quality Record Management Experience (change control, deviations)
  • Supplier evaluations/ assessments (activity)
  • Strong writing skills/ concise communication

Day to Day Responsibilities:
  • Perform Computerized System Periodic Review, Validation, Quality Record Management (change control, deviations)
  • Supplier evaluations/ assessments (activity) periodic reviews

Employee Value Proposition:
Unique opportunity, growth, experience

Red Flags:
No quality assurance experience, no regulated industry experience.
Candidate needs to be a self starter and seasoned in this industry (5+ years would be ideal) - Aerospace, Biotech, pharma highly preferred
Candidate should have strong writing skills and be able to briefly but concisely explain a project


Interview process:
Phone interview then WebEx


We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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