We have other current jobs related to this field that you can find below
-
Audit Senior Associate
4 weeks ago
Boca Raton, United States Kabat, Schertzer, De La Torre, Taraboulos & Co. Full timeMiami, Florida OR Weston, Florida OR Boca Raton, Florida Are you a motivated accounting professional seeking career advancement and the chance to contribute to our cool culture and rapid growth? We have a fun and creative environment with sincere partners and an open door policy. Our culture supports full access to our partners and knowledgeable...
-
Audit Senior
3 days ago
Boca Raton, United States Tandym Group Full timeA professional services firm in Florida is actively seeking an experienced Auditor to join their staff in a Senior-level role. Responsibilities: The Audit Senior will be responsible for: Perform and assist with variety of projects (i.e. audits, reviews, internal audits, agreed upon procedures, consulting projects, etc.) for clients in various industries...
-
Audit Senior Associate
3 months ago
Boca Raton, United States KSDT CPA Full timeJob DescriptionJob DescriptionSalary: Miami, Florida OR Weston, Florida OR Boca Raton, FloridaAre you a motivated accounting professional seeking career advancement and the chance to contribute to our cool culture and rapid growth? We have a fun and creative environment with sincere partners and an open door policy. Our culture supports full access to our...
-
Senior Audit Supervisor
4 days ago
Boca Raton, Florida, United States gpac Full timeJob Overview A reputable CPA firm is seeking to enhance its team by bringing on a Senior Audit Supervisor. This well-established and expanding organization provides its clientele with essential insights and proficiency in taxation. With the firm experiencing significant growth, there is a chance for a Senior Audit Associate to become part of a dynamic and...
-
Food and Beverage Director
2 months ago
Boca Raton, United States Sunrise Senior Living Full timeOverview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air."- Sunrise Leader The Dining Services Director I is responsible for providing outstanding customer service,...
-
Food and Beverage Director
2 months ago
Boca Raton, United States Sunrise Senior Living Full timeOverview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air."- Sunrise Leader The Dining Services Director I is responsible for providing outstanding customer service,...
-
Audit Senior Associate
4 weeks ago
Boca Raton, United States FORVIS Full timeDescription & Requirements Our firm provides assurance services that go beyond the compliance function. Alongside the rest of our team, you will bring credibility to our client's financial picture, communicate information objectively and clearly, and provide insight to help clients improve their businesses.If relationships are important to you and you...
-
Audit Senior Manager | Insurance
1 month ago
Boca Raton, United States FORVIS Full timeDescription & Requirements The Forvis Mazars audit team provides services that go beyond the compliance function. This team brings credibility to our client's financial picture, communicates information objectively and clearly, and provides insight to help clients improve their organizations. How you will contribute: Assisting with managing,...
-
Senior Manager Quality Control Microbiology
3 weeks ago
Boca Raton, United States ADMA Biologics Full timeJob DetailsLevel ManagementJob Location ADMA Biologics FL - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category QA - Quality ControlDescription ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this...
-
Senior Manager Quality Control Microbiology
3 weeks ago
Boca Raton, Florida, United States ADMA Biologics Full timeJob DetailsLevel ManagementJob Location ADMA Biologics FL - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category QA - Quality ControlDescription ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved...
-
Director of Nursing
3 weeks ago
Boca Raton, United States The Mansions at Alpharetta Full timeInspiration lives here. See your future with us! Responsibilities: The Wellness Director reports to the Executive Director and is responsible for the administration of nursing services. He/she directs, plans, and coordinates the services and activities of professional nursing and auxiliary nursing personnel in rendering resident care. The...
-
Senior Project Cost Accountant
2 weeks ago
Boca Raton, United States BBMK Contracting LLC Full timeSenior Project Cost Accountant - Private Sector – BlueTeam ***This position is onsite in Boca Raton, FL*** We are… BlueTeam is a U.S. based service provider specializing in commercial restoration, construction and roofing — both domestic and international — and our clients are the world’s premier commercial portfolio owners and operators. We are a...
-
Executive Director
2 months ago
Boca Raton, United States Veranda Club Full timeJob DescriptionJob DescriptionAbout Discovery Senior LivingDiscovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxurysenior-living communities. With over 250 communities in nearly 40states, and 15,000...
-
IT Risk and Audit Manager
4 weeks ago
Boca Raton, United States TekBank Full timeIT Risk and Audit ManagerWe are unable to sponsor visas for this rolePosition: IT Risk and Audit ManagerLocation: Boca Raton, FL (on-site)Compensation: $65/hr - $75/hr 1099 or C2CSummary:This position leads the IT security risk and audit program for information systems security using generally accepted standards and frameworks for IT audit and risk...
-
IT Risk and Audit Manager
4 weeks ago
Boca Raton, United States TekBank Full timeIT Risk and Audit ManagerWe are unable to sponsor visas for this rolePosition: IT Risk and Audit ManagerLocation: Boca Raton, FL (on-site)Compensation: $65/hr - $75/hr 1099 or C2CSummary:This position leads the IT security risk and audit program for information systems security using generally accepted standards and frameworks for IT audit and risk...
-
Retail & Operations Audit Manager
3 months ago
Boca Raton, United States Jushi Full timeJob DescriptionJob DescriptionRETAIL & OPERATIONS AUDIT MANAGER:Want to make a meaningful difference in peoples’ lives while earning a competitive salary? At Jushi Holdings Inc. ”) (CSE: JUSH) (OTCQX: JUSHF), we are shaping the future of the cannabis industry, the fastest growing jobs sector in the U.S. We identify, evaluate, and acquire U.S.-based...
-
Tax Senior/ Manager
3 days ago
Boca Raton, United States The Execu|Search Group Full timeA professional services firm in Florida is actively seeking an experienced professional to join their staff in Boca Raton as a Tax Director. Responsibilities The Tax Director will be responsible for: Leading and developing Tax Staff and Tax Seniors in a fast-paced, dynamic environment Demonstrating superior client service skills Consulting with market and...
-
Intern Audit Spring 2026
2 months ago
Boca Raton, United States Forvis Mazars Full timeDescription & Requirements As an intern at FORVIS, you will gain valuable experience that may help you decide whether you want to start your career in audit or tax, or even whether public accounting is right for you. You will work on client engagements like those assigned to our entry-level associates, gaining exposure to a variety of industries and testing...
-
Senior Associate Director of Major Gifts
3 months ago
Boca Raton, Florida, United States Saint Andrew's School Full timeSaint Andrew's School in Boca Raton, FL, has engaged DovetailED to lead a search for a Senior Associate Director of Major Gifts beginning July 1, 2024. Interested candidates should review the opportunity statement and submit a cover letter, resume, and list of references with contact information as a single PDF document to DovetailED President Zack Lehman...
-
Senior Project Cost Accountant
3 weeks ago
Boca Raton, United States BlueTeam Full timeJob DescriptionJob DescriptionSenior Project Cost Accountant - Private Sector – BlueTeam***This position is onsite in Boca Raton, FL***We are…BlueTeam is a U.S. based service provider specializing in commercial restoration, construction and roofing — both domestic and international — and our clients are the world’s premier commercial portfolio...
![ADMA BIOMANUFACTURING LLC](https://media.trabajo.org/img/noimg.jpg)
Senior Director, Quality Systems and Audits
2 months ago
Job Location
ADMA Biologics FL - Boca Raton, FL
Description
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Director, Quality Systems and Audits in Boca Raton, FL
The Senior Director, Quality Systems and Audits position leads the department to ensure compliant Quality Management Systems and both internal and external auditing programs are established and maintained in conformity with applicable company and US/worldwide regulatory requirements, standards, guidance and procedures for the development of drugs and biologics. Manage, direct, oversee and continuously improve Quality Management Systems including Deviations, CAPAs, Change Controls, and internal/external auditing. Experienced in hands on projects using Lean Six Sigma (LSS) and risk management processes to improve product quality and process efficiency and efficacy. Leads project management related to FDA inspectional responses and large projects within operations and quality at the Boca site. Other essential duties include quality improvement and root cause analysis related to internal audits, 3rd party audits, regulatory inspections, OOS investigations, deviations, and CAPA's, as needed.
Qualifications
•Develop, establish, improve, and maintain the global QMS elements, including policies, processes, procedures, and controls, enabling successful and efficient development and manufacturing of pharmaceutical products meeting customer and regulatory requirements.
•Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
•Conduct regular audits and inspections, identifying areas for improvement and ensuring compliance with quality standards.
•Analyze data and quality trends, identifying root causes, implementing corrective actions, and preventing future quality deviations.
•Drive supplier quality management initiatives, establishing robust supplier evaluation and qualification processes.
•Quality management of CMOs, contract test laboratories and other vendor services to ensure compliance with manufacturing and testing of company products. Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
•Managing detailed reports on supplier Quality, including defect rates and associated risks.
•Serving as a liaison between our company's senior management and the suppliers to identify quality issues and come up with solutions.
•Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints.
•Experienced in leading regulatory audits and interfacing with regulatory agencies primarily the FDA in either CBER or CDER.
•Promotes a culture of quality and operational excellence and ensures the Quality Systems support the strategic plan to advance the company's Mission, Vision, and Principles.
•Manages and is responsible for the Quality Assurance department which includes managing the staff by providing guidance, training, coaching and strategic leadership. Manage and develop talent that provides overall Quality oversight.
•Oversees tracking and trending of quality systems and presents information/reports to senior level management regarding the status.
•Confirms all Quality Systems are in compliance with cGMPs. Trending and reporting all Quality KPI's on a periodic basis.
•Responsible for all product releases for commercial distribution. Ensures all controlled documents and records meet cGMP requirements.
•Develops processes and guidelines for quality system management and oversees continuous improvements to ensure enhanced compliance to cGMPs and evolving FDA expectations.
•Provides cGMP guidance to internal departments for all phases of product development, as applicable. Participates and represents QA in development project team meetings and discussions.
•Interfaces with other ADMA sites with regards to policies, procedures, and regulatory compliance tools.
•Ensures Quality Systems documents are closed in a timely manner as defined in applicable SOPs.
•Accountable for the Quality Assurance budget adherence including identification of staffing requirements.
•Ensures that the internal and external audit programs are appropriate and robust to identify existing or evolving non-compliances.
•Overall responsibility for the management of FDA audits and inspection responses and projects within quality.
•Drives accountability in meeting defined timelines as part of the project management process.
•Exceptional verbal and written communication skills.
•Demonstrated ability for analytical and systematic thinking. Proficient in risk assessment and root cause analysis tools. Ability to use LSS tools and methodology to implement compliant, simplified processes to ensure enhanced compliance to cGMPs and evolving FDA expectations.
•Ability to manage budget and resourcing and to lead a department.
•Participates in decision making related to critical topics and in decision making as to the strategic direction of the Quality group as a whole.
•Designs and manages quality systems and drives a company-wide culture of cGMP compliance.
•Provides cGMP guidance to internal departments.
Education Requirements:
Bachelor's degree in science or a related technical field.
Experience Requirements:
Minimum of 15 years of experience in the biologics pharmaceutical industry (CBER Regulated); 5-10 years of experience in quality management. Minimum of 5 years as a Team/Department Leader with proven success in coaching, mentoring and improving the overall team performance as determined by standard metrics.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks' Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail
- Free shuttle to the Boca Tri-Rail station
ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.