Location:Thousand Oaks, CA (Remote, able to support PST/EST)
Employment Type: Contract
Business Unit:GxP Computer Systems QA Process Support
Duration:6+ months with likely extensions
3 Key Consulting is hiring aQuality Assurance Managerfor a consulting engagement with our direct client, a leading global biopharmaceutical company.
Remote position; EST and PST hours preferred.In support of clients Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility
- 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
Doctorate degreeorMasters degree and 3 years of directly related experienceor
Bachelors 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.
- 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
Available to work in 2nd shift and non-standard shift.
Why is the Position Open?
Supplement additional workload on team.
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
- 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.
Employee Value Proposition:
Unique opportunity, growth, experience
Phone screening followed by video interview.
We invite qualified candidates to sendyour resume email@example.com. Ifyou decide that youre not interested in pursuing this position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
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