-
Quality Manager
20 hours ago
International SOS Houston, United States**Overall Purpose of Job**: · **T**he Quality Manager (QM) will oversee the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) and Quality Metrics performance. The QM will work with management and functional personnel to pl ...
-
Regional Quality Manager
6 days ago
MAUSER Houston, United States**Position Summary**:The Regional Quality Manager (RQM) is a proactive leader who works under the guidance of Mauser Packaging Solutions corporate policies and procedures. They adhere to all plant safety and health procedures/policies, environmental duties and customer quality st ...
-
Quality Assurance Manager
2 days ago
Audubon Bioscience Houston, United StatesThe Quality Assurance Manager is responsible for leading and managing the implementation, maintenance, and evaluation of quality systems and processes throughout our organization. · **Job Duties**: · - Implement a harmonized and standardized Quality Management System across all t ...
-
Supplier Quality Manager
2 days ago
Amazon Services LLC Houston, United StatesExperience defining program requirements and using data and metrics to determine improvements · - Bachelor's degree · - 5+ years of experience leading continuous improvement initiatives within industry · - Ability to handle ambiguity, function well, and clearly define processes d ...
-
Hospital Quality Manager
2 days ago
Memorial Hermann Health System Sugar Land, United StatesAt Memorial Hermann, we pursue a common goal of delivering high quality, efficient care while creating exceptional experiences for every member of our community. When we say every member of our community, that includes our employees. We know that when our employees feel cared for ...
-
Quality Control Manager
2 days ago
Pink Zebra Home Sugar Land, United StatesOverview: We are seeking a highly skilled and detail-oriented Quality Control Manager to join our team. As the Quality Control Manager, you will be responsible for ensuring that our products meet the highest standards of quality and compliance with FDA regulations. You will play ...
-
Market Manager Quality Risk
1 week ago
HCA Healthcare Houston, United StatesThis position is incentive eligible. · **Introduction**: · Are you ready to manage in a new era as a Market Manager Quality Risk where building a healthier tomorrow is more than a job? Our Surgery Ventures powered by HCA Healthcare team is committed to partnership, innovation, le ...
-
Market Quality Risk Manager
1 week ago
HCA Healthcare Houston, United StatesThis position is incentive eligible. · **Introduction**: · Are you ready to manage in a new era as a Market Quality Risk Manager where building a healthier tomorrow is more than a job? Our Surgery Ventures powered by HCA Healthcare team is committed to partnership, innovation, le ...
-
Construction Quality Control Manager
1 week ago
Bristol Bay Construction Holdings, LLC Houston, United States**Construction Quality Control Manager** · Location**:Houston, TX** · Herman Construction Group, Inc (HCG) is growing We are seeking a talented **Quality Control Manager **to join our dynamic HCG team, a subsidiary of Bristol Bay Construction Holdings LLC (BBCH). As the QC Manage ...
-
Air Quality Project Manager
1 week ago
BGE Inc Houston, United StatesAir Quality Project Manager (Air Compliance/Air Permitting) · BGE is seeking an Air Quality Project Manager in our Environmental Services Department in BGE Inc Headquarters in Houston, TX (West Houston-Westheimer Rd). · **Responsibilities**: · - Communicates scientific and techni ...
-
International SOS Houston, United States**Job description**: · Contracted medical staff will be working alongside uniformed Customs and Border Protection (CBP) Agents/Officers in secured federal facilities along the southwest border of the United States. These secured federal facilities are staffed and monitored by CBP ...
-
Nexus Solutions Jacinto City, United StatesJob Description In this position, you will contribute to the implementation of our quality policy and objectives. You will also support the development of the QM system and optimization of existing processes. Quality Management/Quality Assurance Manager (m/f/d) Your Responsibilit ...
-
Quality Manager
5 days ago
The Reserves Network Houston, United StatesQuality Manager needed to fill a new position for a well-respected client in Houston, TX. Apply today to take advantage of this unique and exciting opportunity · WHAT IS GREAT ABOUT THIS OPPORTUNITY? · Salary of $100,000/year - $120,000/year annually, reflecting your expertise an ...
-
Quality Manager
2 weeks ago
Element Materials Technology Houston, United States**Overview** · Element has an opportunity for an experienced **Quality Manager** . Reporting to the General Manager, you are an essential member of the management team and responsible for the overall quality performance. This includes the Element quality management system (QMS), ...
-
Quality Manager
1 week ago
Element Materials Technology Houston, United States· Quality Manager · Job Locations · US-TX-Houston · ID · Overview · Element has an opportunity for an experienced Quality Manager. Reporting to the General Manager, you are an essential member of the management team and responsible for the overall quality performance. This inclu ...
-
Quality Manager
4 days ago
The Reserves Network Houston, United StatesQuality Manager needed to fill a new position for a well-respected client in Houston, TX. Apply today to take advantage of this unique and exciting opportunity · WHAT IS GREAT ABOUT THIS OPPORTUNITY? · Salary of $100,000/year - $120,000/year annually, reflecting your expertise ...
-
Quality Manager
6 days ago
Element Materials Technology Houston, United StatesOverview: · Element has an opportunity for an experienced Quality Manager. Reporting to the General Manager, you are an essential member of the management team and responsible for the overall quality performance. This includes the Element quality management system (QMS), Prime a ...
-
Quality Manager
1 day ago
Satterfield & Pontikes Houston, United States· Due to growth and expansion we are adding a Quality Manager to oversee our Houston TX region. In this position you will report to our Corporate Quality Manager and working very closely with the local VP. · On top of a competitive base salary we offer annual bonuses, family be ...
-
Quality Manager
1 week ago
Sanhua International Houston, United StatesSanhua is adding a Quality Manager to our Commercial Business. The Quality Manager has ownership of the warranty process and quality issues of Sanhua International's Commercial Team and Commercial Products within North America. Their primary goal will be to ensure product quality ...
-
Quality Manager
1 week ago
Gene by Gene Houston, United StatesJob Description · Job Description Description: Job Summary: · The Quality Manager has the responsibility of ensuring adherence to and · improvement of the Laboratory Quality Plan and of ensuring that compliance with all · accrediting bodies is maintained. · Primary Responsibili ...
Quality Manager - Houston, United States - Fortis Life Sciences
Description
The Opportunity
Fortis Life Sciences is a strategic platform partner providing capital, expertise, and operational resources enabling the growth and success of founder-led life sciences companies.
Fortis was founded in 2020 with the vision of creating a Life Sciences company for top-quality products supported by a superior customer experience.
Fortis' mission is to create a healthier world tomorrow by supporting today's scientific advancement.
The Antibody Solutions Division of Fortis Life Sciences is comprised of three wholly owned subsidiaries: Bethyl Laboratories, Abcore, and Arista Biologicals, Inc.
The Quality Systems Manager position will be based primarily on site at Bethyl Laboratories located in Montgomery, TX which specializes in custom monoclonal and polyclonal antibody production services that support scientific discovery.
Some travel will also be required to the other two Antibody Solution businesses.You'll be working in the fast-growing and rewarding field of life sciences where employees are driven by their passion to learn and make a difference in the world.
The Quality Systems Manager will be hands-on and drive the implementation and refinement of the quality management system designed to be aligned with FDA 21 CFR 820 and ISO 9001/13485.
This position requires a willingness and aptitude to tackle a wide range of challenges, with the ability to internalize the complexities of the Antibody Solutions businesses, Fortis' goals and objectives as well as those of other portfolio companies.
This key individual will provide support involving product design and development, product testing and disposition, quality investigations and cGMP oversight to product manufacturing, evaluation, and release.
As deemed necessary, the Quality Systems Manager may be required to perform other duties not listed on the essential responsibilities.
What You'll Do:
Act as the primary business owner/administrator for the QMS system and fulfills the duties of the Management Representative
Lead in establishing and maintaining quality systems, policies, procedures and controls
Ensure product quality aligns with regulatory requirements and company standards
Work with internal teams to ensure compliance with DHFs, DMRs, DHRs for regulated products
Develop and monitor quality system processes, including CAPA, change control, design control, complaint investigations, supplier oversight, internal audit, nonconforming materials
Plan and manage audits (internal and external) using risk-based assessments, reporting findings and implementing appropriate risk escalation and mitigation strategies
Manage training program, including training plans/schedules, cGMP, new hire QMS overview
Provide data, trending and detailed analyses to support daily quality management
Assemble data, schedule, coordinate, and present data at periodic Management Review meetings to ensure the continued suitability, adequacy and effectiveness of the quality management system
Manage quality system requirements, acceptance activities, and document controls
Promote and advance a Quality Culture across the Antibody Solutions business unit and Fortis by participating in cross site quality forums and activities
Review and approval customer QA agreements and ensure QMS adheres to associated requirements.
Perform product labeling reviews/approvals
Review/approve marketing collateral for Fortis products
Perform other duties & projects as assigned.
Who You Are & What You Bring?
Knowledge and Skills
Quality Systems and Quality Assurance Experience.
Ability to build and integrate QMS systems into a cohesive whole.
Ability to work both strategically and perform hands-on tactical job tasks.
Self-starter who can work well both independently and on cross-functional teams.
Excellent organizational, interpersonal, and communication skills.
Positive attitude and enjoy fast past environments.
Self-confident with ability to assess situations and make sound decisions and/or solve problems autonomously.
Strong sense of urgency
Commitment to continuous improvement
Customer-focus balanced with business sense.
Ability to set priorities and meet deadlines.
Active listener
Education / Background
Bachelor's degree (required), Sciences or Engineering degree preferred
5+ years of Quality experience required in life science or medical device industry
ASQ CQA, CRE, CMDA, CPGP, CQE, CSSBB, CMBB, or CMQ/OE certification a plus
Knowledge and strong understanding of 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971
Familiarity with applicable regulatory requirements for UDSA, DEA, REACH, and drug and/or device manufacturing would be an asset
Experience or knowledge with process validation, 21 CFR 210/211, sterile fill-finish, or software validations a plus
Proficiency with Microsoft Office suite; familiarity with ERP and eQMS desired
Internal, external, or customer audit experience
#J-18808-Ljbffr
