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Job Title: Principal Validation Quality Manager
Location: California, Oakland
Discipline: Quality
Reference: CMMQ9131
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Description:
CMMQ9131
Principal Validation Quality Manager
Oakland, CA
-Leadership Position is responsible for the quality engineering
function of the company's California site supporting manufacturing
of medical devices related to diabetes /new mfg facility builds,
sterilization, and environmental monitoring
-Position's decisions are critical in assuring compliance with applicable
standards/requirements and the ability to successfully meet the business
needs and objectives. The successful management and development of these
quality areas has a direct impact on regulatory compliance and quality
aspects of the business. Additionally, the impact of such guidance,
decisions, and recommendations can have a direct effect on the company's
ability to manufacture new products and manufacture/produce existing
products.
-Leadership Position is responsible for all quality assurance functions of
the
quality engineering department at the California site (this excludes
quality
control). Important partners are manufacturing engineering, QC, regulatory
affairs, and manufacturing as well as the QE managers at the California
extension sites nearby within the company's (DCD) diabetes care division.
-Develop, implement and maintain department operating procedures and
practices that meet the needs of the division and ensures compliance with
all applicable regulatory and corporate requirements as they relate
to validation, change management, and quality engineering
-Take leadership role in managing the continuous improvement
of California site validation master planning, validation
standardization, on-market change management, and manufacturing
quality engineering practices.
-Align department to meet business goals and regulatory compliance
requirements, manage budget, develop and retain staff, ensure department
performance against goals.
-Establish and oversee continuous improvement initiatives as appropriate
for quality engineering and validation of on-site manufacturing processes,
equipment, facility, utilities, and control systems .
- Monitor and report to upper management on quality engineering and
validation related projects
-Responsible for compliance to the site master validation planning,
execution and maintenance. Is the Subject Matter Expert for Validation in
the quality organization.
-Provide hands on support to the manufacturing area as required to assist
in problem solving and long term changes that provide product/process
improvement.Collect and analyze quality information/data from various QS
and develop reports, make data driven recommendation/decisions
- Conceptualize and create validation strategies for validation project
teams. Use engineering or scientific background to understand the
technical
aspects of validation and quality engineering projects and apply the
industry regulations to create a strategy consistent with compliance
needs.
Integrate regulatory and operational needs.
-Oversee the development of quality engineering functional support for the
California site and validation processes as a whole.
- Build and maintain successful cross-functional relationships with
internal customers such as R&D, Engineering, Manufacturing, Operations,
QC and Regulatory Affairs
Qualifications: Minimum Requirements Basic Qualifications:
Must be able to lead the department in addressing technical issues and
working successfully with Operations, Manufacturing and R&D on manufacturing
programs and engineering projects. In order to understand these functions
and the products being developed and manufactured, a degree in one of the
above disciplines is required.
10-14 years overall experience in Quality Assurance or Engineering; minimum
7
years experience in medical device manufacturing or pharmaceutical/Biologics
industries, minimum 4 years experience as a Quality Engineer OR
manufacturing support role, supervisory experience a plus.
- knowledge applicable regulations and standards such as FDA, QSR,
ISO, MDD, & IVDD.
-Strong analytical skills, problem solving techniques and statistical
application experience.
- knowledge in the areas of lean manufacturing, six sigma,
statistical techniques, risk analysis
******Preferred Qualifications*********
Education Requirements BS degree in Chemical, Mechnical, Biomedical, or
Electrical engineering or Science.
Percentage of Travel 5%
Apply to: Click Here
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