- 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.
- 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
- 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
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Quality Manager - Texas, 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:
Who You Are & What You Bring?
Knowledge and Skills
Education / Background
