The Head of Quality Systems, Life Sciences Job

Organization: 
GE Healthcare
Job Location: 
Princeton, NJ
Job Description: 

GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.

The Head of Quality Systems provides leadership and
direction for the quality management system-LS. This position has
accountability for the decisions affecting quality and compliance of key
quality management systems impacting Life Sciences

Essential Responsibilities:

- Translates Global Quality Assurance vision into goals,
objectives strategies and measures for the organization

- Responsible for the quality and compliance performance of
the key global quality management systems including Change Management; Product
Quality Complaint Management; laboratory controls, Deviation and CAPA
Management; Recalls, Post-Market Surveillance oversight and the GMP regulatory
updates

- Drives the deployment and implementation of effective and
efficient quality management systems at GEHC-LS

- Assures communication, document management, and training
for the QMS organization

- Develop, implement, and deploy the necessary processes,
systems and resources to support efficient and effective quality management systems.

- Maintains procedures and policies, requirement flow downs
from applicable standards, regulations and directives as applicable

- Creates transparency, visibility and monitoring of common
quality metrics in the QA organization, across cultures and region/sites with
automated dashboards

- Assure global quality management systems are comprehensive
in nature and are in compliance with applicable regulations, standards, and
GEHC policies

- Direct the global complaint management and deviation and
CAPA management systems and processes

- Provide effective Quality leadership during internal and
health authority inspections of quality management systems

- Provides expertise and guidance in interpreting government
regulations, agency guidelines and internal procedures to assure continued
compliance of quality management systems

- Assure CAPA process is functioning to support on-time,
audit ready and effective solutions to significant events and trends.

Requirements:
Qualifications/Requirements:

1. Bachelor's degree and a minimum of 12 years Quality Assurance
and/or Quality Systems experience in the pharmaceutical industry (preferred)
with some exposure to medical devices and IVD regulations
2. Minimum of 8 years of experience managing/supervising
others
3. Demonstrated superior knowledge and expertise in the
design, creation, and maintenance of Quality System Manual with emphasis in
Pharmaceutical/Drugs regulations USA and worldwide
4. Significant QC/laboratory control experience, in
particular creating and managing laboratory controls such as laboratory
deviations, stability programs, laboratory equipment qualification, etc.
5. Exposure to medical devices Quality Systems including ISO
13485:2003
6. Significant expertise dealing with regulators and
government agencies in market corrections and removals
7. Exposure to FDA-Field Alerts, BPDR, and 806
8. Demonstrated skills and abilities to successfully
interact with Regulatory Authorities and in managing Regulatory Authority
audits and inspections
9. Proven ability to work effectively with cross-functional
stakeholders in a complex, changing, and global environment
10. Willingness to travel globally 25-30% of the time
including potential extended period of times assisting sites in preparation and
remedial activities

Additional Eligibility Qualifications GE will only employ
those who are legally authorized to work in the United States for this opening.
Any offer of employment is conditioned upon the successful completion of a
background investigation and drug screen.

Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics:

1. Advanced Life Sciences Degree
2. Experience interfacing with FDA and global regulatory agencies and ability to interface with central governmental regulators
3. Strong business acumen; uses financial analysis to make important business decisions and understand key financial metrics, can articulate the company?s business vision and key business objectives, understands business trends and cycles
4. Experience in multi-QMS (Pharma/Drugs, Medical Devices, IVD, and CLIA) management systems
5. Extensive understanding of laboratory controls, quality control environments including chemistry and microbiological labs.
6. Able to respond/react with appropriate urgency/professionalism and make decisions under pressure/stress
7. Ability to comprehend and communicate/translate key regulatory body requirements/expectations and ability to read, analyze, and interpret scientific and technical journals, financial reports and legal documents.
8. Ability to respond to escalated inquiries/complaints from customers/regulatory bodies and members of the business community
9. Ability to detect trends/shifts in requirements and align/shift internal organization priorities and actions accordingly
10. Demonstrated ability to lead teams across regions/cultures/sites.
11. Thorough understanding of Operations and Quality, particularly how a manufacturing site and/or regions, sales, and service sites function.
12. Ability to help design and implement IT solutions related to compliance and process improvement.