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Senior Director, Quality Systems and Audits

2 months ago

Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time
Job Details

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.