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Quality Assurance Manager, Biopharma – Remote (JP10218)
Thousand Oaks, CA · Biotech/PharmaceuticalJob 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:
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
Available to work in 2nd shift and non-standard shift.?
Why is the Position Open?
Staff Augmentation
Top Must-Have Skill Sets:
Day to Day Responsibilities:
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.
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
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